Significant FDA brand approvals for 2009
This is a discussion on Significant FDA brand approvals for 2009 within the New Brand Drug Approvals by Month forum, part of the New Drug Approvals and Pipeline category; Listed below you will find the significant brand approvals for 2009, organized by therapeutic areas with regards to new chemical ...
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12-30-2009, 11:45 AM
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Significant FDA brand approvals for 2009
 Listed below you will find the significant brand approvals for 2009, organized by therapeutic areas with regards to new chemical entities, new dosage forms/formulations, significant expanded indications and new OTC switches. New chemical entities: Antiinfectives: Coartem (artemether/lumefantrine) by Novartis Approval: treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds); not approved for treatment of severe malaria nor for prevention of malaria • Link to FDA letterVibativ (televancin) injection by Theravance Approval: once-daily treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains; 4Q09 launch expected •Link to Theravance press release 9/09Antineoplastics: Afinitor (everolimus) 5,10mg tablets by Novartis Approval: treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib (Sutent) or sorafenib (Nexavar) -Novartis expects to be a blockbuster ($1B/yr); also being studied in breast, gastric, and non-small cell lung cancers • Link to news article 4/09Folotyn (pralatrexate) injection by Allos Therapeutics Accelerated approval: treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) •Link to FDA letterIstodax (romidespin) IV by Gloucester Pharmaceuticals Approval: treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy; expected to be available in 1/2010 •Link to Gloucester press release 11/09Votrient (pazopanib) by GlaxoSmithKline Approval: an oral kinase inhibitor for the treatment of advanced renal cell carcinoma (RCC) •Link to GSK press release 10/09Cardiovascular: Effient (prasugrel) 5, 10mg tablets by Eli Lilly/Daiichi Sankyo Approval: P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows: •Patients with unstable angina or, non-ST-elevation myocardial infarction (NSTEMI) •Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI •Link to FDA letter Related links:Livalo (pitavastatin) 1, 2, 4mg tablets by Kowa Pharmaceuticals and Lilly Approval: primary treatment of hypercholesterolemia and combined dyslipidemia; expected to be launched 1Q2010 •Link to Kowa press release 8/09Multaq (dronedarone) tablets by sanofi-aventis Approval:antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted •Link to sanofi-aventis press release 7/09CNS: Fanapt (iloperidone) tablets by Vanda Pharmaceuticals Approval: acute treatment of schizophrenia in adults •Of note, drug available later in 2009; this product has the class-antipsychotic boxed warning for increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis; drug not approved for patients with dementia-related psychosis •Link to FDA letterSabril (vigabatrin) tablets and oral solution by Lundbeck Approval: monotherapy for pediatric patients one month to two years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss AND as adjunctive therapy for adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss; not indicated as a first-line agent for CPS -IS is characterized by spasms that may occur in clusters of up to 100 at a time -Sabril is the 1st FDA approved medication to treat IS -Drug to be available 3Q09 -REMS program (to manage the risk of permanent vision loss) will be administered through Lundbeck's SHARE (Support, Help and Resources for Epilepsy) program •Link to Lundbeck press release 8/09Saphris (asenapine) sublingual tablet by Schering-Plough Approval: acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults; can be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both of these indications simultaneously; launch expected in 4Q09 •Link to Schering-Plough press release 8/09Savella (milnacipran) tablets by Forest and Cypress Approval: SNRI indicated for the management of fibromyalgia, but not for use in pediatric patients; should be available in pharmacies by 3/09 •Link to prescribing informationEndocrine and Diabetes: Onglyza (saxagliptin) by Bristol Myers Squibb and AstraZeneca Approval: treatment of type 2 diabetes mellitus in adults •Link to AstraZeneca press release 8/09Samsca (tolvaptan) tablets by Otsuka Approval: treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH) •Drug should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely due to the risk of overly rapid correction of hyponatremia •Link to Otsuka press release 5/09Uloric (febuxostat) 40, 80mg tablets by Takeda/Teijin Approval: once-daily xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout • Link to prescribing informationHematologic agents: Feraheme (ferumoxytol) Injection by Amag Pharmaceuticals Approval: IV iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD) •Link to Amag press release 6/09Lysteda (tranexamic acid) oral tablets by Xanodyne Approval: treatment of cyclic heavy menstrual bleeding •Link to Xanodyne press release 11/09Ophthamology: Bepreve (bepotastine besilate ophthalmic solution) 1.5% by Ista Approval: twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older; 4Q09 launch expected •Link to Ista press release 9/09Besivance (besifloxacin ophthalmic suspension) 0.6% by Bausch and Lomb Approval: treatment of bacterial conjunctivitis; will be available in pharmacies by 2Q09 •Link to press release 5/09Topicals: Microsyn Skin and Wound Gel by Oculus Innovative Sciences and Advocos Approval: management of exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgically debrided wounds •available as in OTC/Rx forms; reimbursable by both Medicare and Medicaid •Link to press release 5/09New biologics: Antineoplastics: Arzerra (ofatumumab) by GlaxoSmithKline Accelerated approval: CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab •Link to GSK press release 10/09Cardiovascular agents: ATryn (Antithrombin [Recombinant]) Approval: prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients -first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the U.S -expected to be used only in the in-patient setting -drug available 5/09 • Link to prescribing informationCNS: Dysport (abobotulinumtoxinA) by Medicis and Ispen Approval: the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain, AND the temporary improvement in the appearance of moderate to severe glabellar lines in adults younger than 65 years of age •Medicis to launch for glabellar lines within the next 30-60 days and Ipsen to launch for cervical dystonia during 2H2009 •Link to Medicis press release 5/09Enzyme replacements and modifiers: Berinert (C1 esterase inhibitor, human) by CSL Behring Approval: treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients; the safety and efficacy of Berinert for prophylactic therapy has not been established •Link to FDA letter Related links:Kalbitor (ecallantide, DX-88) SC injection by Pfizer Approval: plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 6 years of age and older •Link to Dyax press release 11/09Prolastin-C (Alpha1-Proteinase Inhibitor [Human]) by Talecris Biotherapeutics Approval: treatment of alpha1-antitrypsin (AAT) deficiency (Prolastin-C delivers twice the active protein per milliliter as Prolastin, cutting infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min) •Link to news article 10/09Hematologic agents: RiaSTAP Fibrinogen Concentrate (Human) by CSL Behring Approval: treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia • Link to prescribing informationWilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human) by Octapharma Approval: treatment of spontaneous or trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated •Link to FDA letterImmunologic agents: Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant) by GlaxoSmithKline Approval: prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and cervical intraepithelial neoplasia (CIN) grade 1, caused by oncogenic human papillomavirus (HPV) types 16 and 18, in females 10 through 25 years of age •Link to FDA letterClinical differentiation (Cervarix vs. Gardasil): •According to the American Cancer Society, of all cervical cancers related to HPV, 70% are caused by HPV types 16, 18. Both are covered by the Cervarix and Gardasil vaccines.Extavia (interferon beta-1b) by Novartis Approval: treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The therapy is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging (MRI); launch expected this fall •Link to Novartis press release 8/09Gammaplex (Immune Globulin Intravenous (Human) by BioProducts Laboratory Approval: For the treatment of primary humoral immunodeficiency (PI) •Link to FDA letterHiberix Haemophilus influenza type b (Hib) vaccine by GSK Accelerated approval: booster dose for children aged 15 months through 4 years •Link to News article 8/09Ilaris (canakinumab) injection for SC use by Novartis Approval:treatment for children and adults with cryopyrin-associated periodic syndrome (CAPS); first approved treatment for patients as young as four years old suffering from two forms of CAPS: familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) •Link to Novartis press release 6/09 •Link to prescribing informationIxario (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) by Intercell Approval: active immunization for the prevention of disease caused by Japanese encephalitis virus (JEV) in persons 17 years of age and older • Link to FDA letterSimponi (golimumab) by Centocor OrthoBiotech Approval: in combination with methotrexate (MTX) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), alone or in combination with MTX for the treatment of adult patients with active psoriatic arthritis (PsA) and for the treatment of adult patients with active ankylosing spondylitis (AS) •Link to Centocor OrthoBiotech press release 4/09Stelara (ustekinumab) injection by Centocor Ortho Biotech Approval: human interleukin-12 and -23 antagonist indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy •Link to FDA news release 9/09Topicals: Sculptra Aesthetic (poly-L-lactic acid) injection by sanofi-aventis Approval:correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy patients •Link to sanofi-aventis press release 7/09New dosage forms/formulations/combinations: Antiinfectives: Solodyn (minocycline) extended-release tablets by Medicis New dosage strengths: Extended Release Tablets in 65mg and 115mg dosages for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older (Solodyn also comes in 45, 90, 135mg and is generically available in these strengths) •Link to Medicis press release 7/09Tyzeka (telbivudine) oral solution by Novartis Approval: treatment of chronic hepatitis B (CHB) in adult patients with evidence of viral replication and active liver inflammation and CHB patients with renal impairment who may require a dose reduction •Link to FDA letterAntineoplastics: Oforta (fludarabine phosphate film-coated tablets) by sanofi-aventis Approval: for use as a second-line therapy to treat adults with B-cell chronic lymphocytic leukemia (CLL) •approved by FDA in 12/08, acquired by sanofi-aventis (5/09); drug availability TBD •Link to prescribing informationTemodar (temozolomide) for injection 100 mg/vial by Schering New dosage form indication: for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and also for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine -already available in oral formulation • Link to FDA letterCardiovascular: Adcirca (tadalafil) tablets by United Therapeutics Approval:treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability •Link to prescribing informationclonidine 24-hour sustained release tablets and suspension (brand name has not been disclosed) by TrisPharma Approval: treatment of hypertension •Link to TrisPharma press releasesExforge HCT (amlodipine, valsartan, and hydrochlorothiazide) by Novartis Approval: treatment of hypertension; patients can switch to the combination if their blood pressure is not adequately controlled on dual combinations of its components •Link to Novartis press release 4/09Fibricor (fenofibric acid) 35, 105mg tablets by Mutual Pharma Approval: To reduce triglyceride (TG) levels in patients with severe hypertriglyceridemia (> 500 mg/dl) AND to reduce elevated total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), TG and apolipoprotein (Apo) B and to increase high-density lipoprotein cholesterol (HDL-C ) in patients with primary hyperlipidemia or mixed dyslipidemia. •Link to FDA letterNexterone (amiodarone HCl) injection Approval:cosolvent free formulation; indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy; originally marketed in the US by Wyeth as Cordarone Intravenous • Link to prescribing informationRevatio (sildenafil) injection by Pfizer Approval: treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening •Link to FDA letterSotalol 150mg injection by Academic Pharmaceuticals Approval: 1st injectable version of sotalol approved as substitution for oral sotalol in patients who are unable to take sotalol orally •Link to prescribing informationTwynsta (telmisartan/amlodipine) by Boehringer Ingelheim Approval: treatment of hypertension alone or in combination with other anti-hypertensive agents, or as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals •Link to BI press release 10/09Tyvaso (treprostinil) inhalation solution by United Therapeutics Approval: prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III symptoms, to increase walk distance •Link to United Therapeutics press release 7/09Valturna (aliskiren/valsartan) tablets by Novartis Approval: treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals •Link to Novartis press release 9/09CNS: Caldolor (ibuprofen) injection by Cumberland Pharmaceuticals Approval: treatment of pain and fever; the product will be available for hospital use only •Link to Cumberland press release 6/09Cambia (diclofenac potassium) oral solution by Kowa Approval: acute treatment of migraine attacks with or without aura in adults 18 years of age or older; expected to be launched in 4Q09 •Link to prescribing information •Link to news article 6/09Edluar (zolpidem; formerly known as Sublinox) 5 mg and 10 mg sublingual tablets by Orexo Approval: for the short-term treatment of insomnia characterized by difficulties with sleep initiation -manufacturer to market 2H09 • Link to News article 3/09Embeda (morphine sulfate and naltrexone hydrochloride) extended release capsules by King Approval: Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time; launch expected 9/09 •Link to King press release 8/09Intuniv (guanfacine) extended-release tablets by Shire Approval: once-daily treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years •Link to Shire press release 9/09Lamictal ODT (lamotrigine 25mg, 50mg, 100mg, 200mg orally disintegrating tablets) by GlaxoSmithKline Approval: long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in adults 18 years or older who have been treated for mood episodes with other medicine and as an antiseizure treatment for epilepsy •should be available in pharmacies by early July 2009 •Link to FDA letterLamictal XL (lamotrigine) extended release tablets by GlaxoSmithKline Approval: once-daily adjunctive therapy for partial-onset seizures with or without secondary generalization in epileptic patients aged 13 years and older •Link to news article 6/09Invega Sustenna (paliperidone palmitate) extended-release injectable suspension by Johnson & Johnson/Janssen Approval: acute and maintenance treatment of schizophrenia in adults •Link to J&J press release 7/09Nexcede (12.5 mg ketoprofen) oral soluble film by Novartis Approval: temporary relief of minor aches and pains due to headache, toothache, backache, menstrual cramps, the common cold, muscular aches, minor pain of arthritis, and the temporary relief of fever •Link to FDA letterOnsolis (fentanyl buccal soluble film), CII by BioDelivery Sciences International Approval: indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain •Link to FDA letterRyzolt (tramadol) extended release tablets Approval: management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time; drug will be available 2Q09 • Link to FDA letterSumavel DosePro (sumatriptan injection) by Zogenix Approval: treat acute migraine, with or without aura, and cluster headache; needle-free delivery system; product to be available "as soon as possible" •Link to Zogenix press release 7/09Synvisc One (hylan G-F 20) by Genzyme Approval: relief of pain associated with osteoarthritis (OA) of the knee -single-injection, which can provide relief for 6 months -therapy will be made available immediately • Link to Genzyme press release 2/09Zipsor (diclofenac potassium) liquid-filled capsules by Xanodine Approval: for relief of mild to moderate acute pain; dosed 4x/day •Link to prescribing informationZyprexa Relprevv (olanzapine) extended release injectable suspension by Eli Lilly Approval: long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia •Link to Eli Lilly press release 12/09Endocrine/diabetes: ACTOplus met XR (pioglitazone HCl and metformin HCl) tablets by Takeda Approval: once daily as an adjunct to diet and exercise for the treatment of type 2 diabetes •available late 2009 •Link to press release 5/09Colcrys (colchicine) by United Therapeutics Approval: gout flares and Familial Mediterranean fever (FMF) in adults and children 4 years or older; (oral colchicine has been used for many years as an unapproved drug; FDA is trying to bring unapproved, marketed products to approval with regards to updated safety, efficacy, regulatory requirements) •Link to News release 7/09Cycloset (bromocriptine) by Wythe/VeroScience Approval: treatment of type 2 diabetes •Link to FDA letterTev-Tropin Tject Injection System (somatropin) by Teva and Antares Approval: needle-free injector for the treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone (GH) •Link to news article 6/09Gastrointestinal agents: Creon (pancrelipase) delayed release capsules by Solvay Approval: treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions •Link to FDA letteromeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole by Santarus Approval: treatment of heartburn and other symptoms associated with GERD; however, the FDA has not yet approved a trade name for the new product (Santarus has submitted a proposed trade name that includes the "Zegerid" brand name and expects FDA will complete its review of this NDA supplement within 180 days and will launch following that approval •Link to Santarus press release 12/09Zenpep (pancrelipase) 500 lipase units [USP] by Eurand Approval: for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions. •Link to FDA letterMetozolv ODT (metoclopramide) orally-disintegrating 5,10mg tablets by Salix Approval: relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis and for the treatment of short–term therapy (4–12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy; expected to be available 11/09 •Link to Salix press release 9/09Obstetrics and Gynecology: Plan B One-Step (levonorgestrel) 1.5mg tablet by Duramed Approval: progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Plan B One-Step is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. •Link to prescribing informationVagifem (10mcg estradiol vaginal tablets) by Novo Nordisk Approval: treatment of atrophic vaginitis due to menopause; lowest local estrogen therapy (LET) dose commercially available in the US; will be available in pharmacies 1Q2010 •Link to Novo Nordisk press release 12/09Ophthamology: Acuvail (ketoprofen) ophthalmic solution by Allergan Approval: preservative-free formulation, indicated for the treatment of pain and inflammation following cataract surgery; available in 9/09 •Link to Allergan press release 7/09Orzudex (dexamethasone) intravitreal implant by Allergan Approval: treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) •Link to prescribing information •Link to news article 6/09Tobradex ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05% by Alcon Approval: for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists • Link to FDA letterZirgan (ganciclovir 0.15% ophthalmic gel) by Sirion Therapeutics Approval: for the treatment of acute herpetic keratitis, also known as dendritic ulcers •Link to FDA letterRenal and urologic agents: Renvela (sevelamer carbonate) 0.8 and 2.4 grams powder packets by Genzyme Approval: control of serum phosphorus in patients with chronic kidney disease on dialysis •Link to FDA letterRespiratory agents: AllerNaze (triamcinolone) nasal spray Approval: once-daily treatment of nasal symptoms associated with both seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and children 12 years of age and older • Link to Collegium press release 1/09Astepro (astelazine) nasal spray 0.15% by Meda Approval: once-daily treatment for the symptoms of seasonal and perennial allergic rhinitis (SAR and PAR); available early October 2009 •Link to Meda press release 9/09Topicals: Cetraxal (ciprofloxacin 0.2% otic solution) by Laboratorios Salvat Approval: treatment of acute otitis externa due to susceptible isolates of Pseudomonas aerugenosa or Staphylococcus aureus •Link to FDA letterXerese (previously known as Lipsovir) (acyclovir/hydrocortisone) cream by Medivir Approval: early treatment of recurrent herpes labialis; to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time; approved for adults and children aged 12 years and older •Link to News article 8/09Pennsaid Topical Solution (diclofenac sodium topical solution) 1.5% by Nuvo/Covidien Approval: treatment of the signs and symptoms of osteoarthritis of the knee •Link to Nuvo press release 11/09Qutenza (capsaicin) 8% patch by NeurigesX Approval: TRPV I channel agonist indicated for the management of neuropathic pain associated with postherpetic neuralgia (PHN); plans to commercialize in 1H2010 •Link to NeurogesX press release 11/09Ulesfia (benzyl alcohol lotion, 5% by Sciele Approval: treatment of head lice (pediculosis capitis) infestation in patients 6 months and older • Link to FDA news article 4/09Expanded indications: Antiinfectives: Isentress (raltegravir) Expanded indication: treatment of HIV-1 infection in treatment-naive patients. The recommended dose for treatment-naive adult patients is Isentress 400 mg twice daily, with or without food. •Link to prescribing informationAntineoplastics: Avastin (bevacizumab) by Genentech Expanded indication: treatment of metastatic renal cell carcinoma in combination with interferon alfa •Link to FDA letterGleevec (imatinib mesylate) by Novartis Expanded indication: treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in the chronic phase •Link to FDA letterCardiovasular agents: Crestor (rosuvastatin) by AstraZeneca Expanded indication: for use in children ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol •Link to AZ press release 10/09Micardis (telmisartan) by Boehringer Ingelheim Expanded indication: 80mg dose - reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events, who are unable to take angiotensin-converting enzyme (ACE) inhibitors •Link to BI press release 10/09Tekturna HCT (aliskiren/hydrochlorothiazide) Expanded indication: use as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals with a single agent •Link to FDA letterCNS: Abilify (aripiprazole) by BMS Expanded indication: treatment of irritability associated with autistic disorder for pediatric patients (ages 6-17 years •Link to BMS press release 11/09Axert (almotriptan) by OrthoMcNeil Janssen Expanded indication: cute treatment of migraine headache in adolescents aged 12 to 17 years. Almotriptan previously was approved for use in adults only • Link to FDA letterCymbalta (duloxetine) by Eli Lilly Expanded indication: for the maintenance treatment of generalized anxiety disorder (GAD) in adults •Lilly press release 11/09Lexapro (escitalopram oxalate) by Forest Expanded indication: acute and maintenance treatment of major depressive disorder (MDD) in adolescents, aged 12 to 17 • Link to Forest press release 3/09 • Link to prescribing information Seroquel (quetiapine) by AstraZeneca Expanded indication: treatment of schizophrenia in adolescents (13-17 years of age) as monotherapy, and for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age), both as monotherapy and as an adjunct to lithium or divalproex •Link to AstraZeneca press release 12/09Seroquel XR (quetiapine extended release) by AstraZeneca Expanded indication: adjunctive treatment to antidepressants in adults with Major Depressive Disorder (MDD) •Link to AstraZeneca press release 12/09Symbyax (olanzapine and fluoxetine HCl) by Eli Lilly Expanded indication: acute treatment of treatment-resistant depression (TRD) • Link to Lilly press release 3/09Zyprexa (olanzapine) by Eli Lilly Expanded indication: treatment of schizophrenia and manic or mixed episodes of bipolar I disorder in adolescents aged 13 to 17 years •Link to Lilly press release 12/09Endocrine/diabetes: Byetta (exenatide) by Amylin Expanded indication: monotherapy for use along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Safety issue: strengthened warning relating to the risks of pancreatitis and for use by patients with severe kidney disease; patients with "severe kidney problems" should not take the drug and should be "used with caution" for those with a kidney transplant •Link to prescribing informationReclast (zoledronic acid) by Novartis Expanded indication: first and only therapy to prevent postmenopausal osteoporosis for two years with a single dose •Link to Novartis press release 6/09Immunologic agents: Cimzia (certolizumab pegol) Expanded indication: treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) •1st available pegylated anti-TNF agent for RA; can be dosed at 400 mg initially and at weeks 2/4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered. •Link to UCB press release 5/09Copaxone (glatiramer acetate) injection by Teva Expanded indication: for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. • Link to FDA letterGardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant) by Merck Expanded indication: for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11 •Link to Merck press release 10/09PegIntron (pegylated interferon alfa-2b) and Rebetol (ribavirin) by Schering Plough Expanded indication: combination therapy for treating chronic hepatitis C in patients 3 years of age and older with compensated liver disease; first pegylated combination therapy not restricted to treatment-naive patients • Link to Schering Plough press release 3/09OTC switches: Gastrointestinal agents: Prevacid 24HR (lansoprazole delayed-release 15mg capsules) by Novartis Approval: treatment of frequent heartburn •first prescription strength PPI to be approved for OTC use; launched 11/09 •Link to Novartis press release 5/09Zegerid OTC (20 mg omeprazole & 1100 mg sodium bicarbonate capsules) by Schering-Plough Approval: treatment of frequent heartburn (occurs 2 or more days per week) •Link to FDA letterObstetrics and Gynecology Plan B One-Step (levonorgestrel) 1.5mg tablet by Duramed Approval: progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Plan B One-Step is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. •Link to prescribing information Last edited by chantell.reagan : 02-18-2010 at 01:51 PM. 
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02-04-2010, 12:03 PM
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Re: Significant FDA brand approvals for 2009
We received this question from one of our members:
"Do you have any information on the when Zegerid will have OTC status? Also, what strength will the OTC product be? Thanks!"
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02-04-2010, 01:46 PM
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Re: Significant FDA brand approvals for 2009
Zegerid OTC was approved by the FDA in December 2009. Though it hasn't been launched, it is expected to be released in 1H2010 by Merck-Schering. The OTC version will be available in 20 mg omeprazole & 1100 mg sodium bicarbonate capsules. Of note, another prescription combination PPI (Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets, 20 mg/750 mg/343 mg and 40 mg/750 mg/343 mg) was approved in December 2009. Though the name is yet to be released, it will likely include "Zegerid" as part of the brand.
Sources: Over-the-counter Today 12/09 Related links: FDA update on brand drugs for December 17, 2009 FDA update on brand drugs for December 3, 2009
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| Thread | Thread Starter | Forum | Replies | Last Post |
| First-time generic approvals in November 2009 | chantell.reagan | New Generic Approvals by Month | 0 | 12-01-2009 04:58 PM |
| First-time generic approvals in October 2009 | chantell.reagan | New Generic Approvals by Month | 1 | 11-12-2009 10:48 AM |
| First-time generic approvals in July 2009 | chantell.reagan | New Generic Approvals by Month | 0 | 08-04-2009 11:51 AM |
| First-time generic approvals in June 2009 | chantell.reagan | New Generic Approvals by Month | 3 | 07-02-2009 01:53 PM |
| First-time generic approvals in May 2009 | chantell.reagan | New Generic Approvals by Month | 0 | 06-02-2009 11:54 AM |
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