New brand drugs approved in 2008

[chantell.reagan]

New brand drug approvals in 2008:

Accretropin (somatropin) by Cangene
Approval: treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone and treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed
•Link to prescribing information:

•Prescribing information

Akten (lidocaine 3.5% ophthalmic gel) by Akorn
Approval: for ocular surface anesthesia during ophthalmologic procedures
•Link to FDA Letter:

•FDA Letter

Alvesco (ciclesonide) by Nycomed
Approval: maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older; not indicated for the relief of acute bronchospasm
•Link to prescribing information:

•Prescribing information

Aplenzin (bupropion hydrobromide) extended release tablets by Bioavail Pharmaceuticals
Approval:treatment of major depressive disorder
•Link to prescribing information:

•Prescribing information

Apriso (mesalamine extended–release capsules) by Salix
Approval: maintenance of remission of ulcerative colitis (UC) in adults; launch expected in 1Q09
•Link to press release:

•Salix press release

Arcalyst (rilonacept) by Regeneron
Approval: treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older
•Link to prescribing information:

•Prescribing information

Astepro (azelastine hydrochloride) nasal spray by Meda
Approval: for the relief of symptoms of seasonal allergic rhinitis in patients 12 years of age and older
•Link to FDA Letter:

•FDA Letter

Banzel (rufinamide) by Eisai
Approval: adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years and older and adults
•Link to press release:

•Eisai press release 11/08

•Link to FDA letter:

•FDA letter

•Link to prescribing information:

•Prescribing information

Cimzia (certolizumab) by UCB, Inc.
Approval: reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
•Link to prescribing information:

•Prescribing information

Cinryze (C1 inhibitor, human) by Lev Pharmaceuticals
Approval: for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE)
•Link to FDA Letter:

•FDA Letter

•Link to prescribing Information:

•Prescribing Information

Cleviprex (clevidipine butyrate) injectable emulsion by the Medicines Company
Approval: for the reduction of blood pressure when oral therapy is not feasible or not desirable
•Link to prescribing information:

•Prescribing information

degarelix by Ferring Pharmaceuticals
Approval:injectable GnRH receptor inhibitor for advanced prostate cancer
•Link to press release:

•FDA News Release 12/08

• Link to prescribing information:

oPrescribing information

Durezol (difluprednate) by Sirion
Approval: treatment of inflammation and pain associated with ocular surgery (as an ophthalmic emulsion)
•Letter from FDA:

•Letter from FDA

•Prescribing information:

•Prescribing information

Epiduo (adapalene 0.1 % and benzoyl peroxide 2.5 %) by Galderma labs
Approval: treatment of acne when comedones, papules, and pustules are present
•Link to press release:

•News article 12/08

Intelence (etravirine) by Tiobec
Approval: used in combination with other antiretrovirals for patients who have evidence of viral replication/HIV-1 resistant strains to an NNRTI or other antiretrovirals
•Link to prescribing information:

•Prescribing information

Latisse (bimatoprost ophthalmic solution) 0.03% by Allergan
Approval: indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness; will be available 1Q09
•Note: this product has same active ingredient as Lumigan (with eyelash growth as a known side effect); packaged as an opthalmic solution, with 60 disposable applicators for application to skin of the upper eyelid margin at the base of the eyelashes
•Link to press release:

•Allergan press release 12/08

•Link to prescribing information:

•Prescribing information

Levoleucovorin® (levofolinic acid) by Spectrum Pharmaceuticals, Inc.
Approval: as rescue therapy after high-dose methotrexate therapy in osteosarcoma; and to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists
•Link to prescribing information:

•Prescribing information

LoSeasonique (levonorgestetrel/ethinyl estradiol/ethinyl estradiol) by Duramed
Approval: oral contraception (extended cycle) for the prevention of pregnancy
•Link to press release:

•Barr press release

•Link to FDA letter:

•FDA Letter

Moxatag (amoxicillin 775mg extended release) by Middlebrook Farms
Approval: penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years or older
•Link to prescribing information:

•Prescribing information

Mozobil (plerixafor) injection by Genzyme
Approval: indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma; this product is likely to be used in transplant centers
•Link to press release:

•Genzyme press release 12/08

•Link to prescribing information:

•Prescribing information

Novolog Mix 50/50 by NovoNordisk
Approval: for control of hyperglycemia in patients with diabetes mellitus
•Link to FDA Letter:

•FDA Letter

Nplate (romiplostim) by Amgen
Approval: treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
•Link to FDA Letter:

•FDA Letter

•Link to Prescribing information:

•Prescribing information

Patanase (olopatadine hydrochloride) Nasal Spray by Alcon Research
Approval: relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older
•Link to prescribing information:

•Prescribing information

Pristiq (desvenlafaxine) by Wyeth
Approval: SNRI indicated for the treatment of major depressive disorder (MDD)
•Link to prescribing information:

•Prescribing information

Promacta (eltrombopag) by GlaxoSmithKline
Approval: treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy
•Link to press release:

•GSK press release 11/08

•Link to prescribing information:

•Prescribing information

Rapaflo (silodosin) by Watson
Approval: for the treatment of the signs and symptoms of BPH
•Link to press release:

•Watson press release 10/08

Relistor (methylnaltrexone bromide) subcutaneous injection by Wyeth
Approval: treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient
•Link to prescribing information:

•Prescribing information

Sancuso (transdermal granisetron) by Strakan
Approval: prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration
•Link to FDA Letter:

•FDA Letter

•Link to prescribing information:

•Prescribing Information

SCE-A Vaginal Cream (Synthetic Conjugated Estrogens-A 0.625 mg/g) by Duramed
Approval: treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause
•Clinical pearls:

•This product is a synthetic, plant-derived estrogen product, as compared to Premarin, which is derived from urine of pregnant horses.

•Administered intravaginally at a dose of 1 gram daily for one week, followed by 1 gram intravaginally twice a week

•Will be available 1Q09

•Link to FDA letter:

•FDA letter

•Link to press release:

•Barr press release 12/08

•Link to prescribing information:

• Prescribing information

Simcor (niacin/simvastatin) by Abbott
Approval: reduce elevated total–C, LDL-C, Apo B, non-HDL-C, TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate AND to reduce TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia) when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate
•Link to prescribing information:

•Prescribing information

Stavzor (valproic acid) by Banner Pharmacaps
Approval: treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy in multiple seizure types and prophylaxis of migraine headaches
•Letter from FDA:

•Letter from FDA

•Prescribing information:

•Prescribing information

tapentadol by Johnson and Johnson
Approval: immediate-release oral tablet for the relief of moderate to severe acute pain
•Link to press release:

• J&J Press release 11/08

Tekturna HCT (aliskiren/HCTZ) by Novartis
Approval: treatment of hypertension in used alone or in combination with other antihypertensives
•Link to prescribing information:

•Prescribing information

Toviaz (fesoterodine fumarate) by Pfizer
Approval: once-daily treatment of overactive bladder (OAB) symptoms; available 1st half of 2009
•Link to press release:

•Pfizer press release

•Link to prescribing information:

•Prescribing information

Treanda (bendamustine) by Cephalon
Approval: treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established
•Link to prescribing information:

•Prescribing information

Treximet (sumatriptan/naproxen) by GlaxoSmithKline
Approval: acute treatment of migraine attacks with or without aura in adults
•Link to prescribing information:

•Prescribing information

Trilipix (fenofibric acid) delayed release capsules by Abbott
Approval: in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal AND as monotherapy to reduce TG in patients with severe hypertriglyceridemia AND as monotherapy to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia
•Link to press release:

•Abbott press release 12/08

•Link to prescribing information:

•Prescribing information

Trivaris (triamcinolone acetonide) by Allergan
Approval: for ophthalmic, intramuscular, and intra-articular use (as an injectable suspension)
•Link to prescribing information:

•Prescribing information

Vimpat (lacosamide) tablets and injection by Schwartz Biosciences
Approval: adjunctive therapy for partial-onset seizures (tablets); njection is indicated as short term replacement when oral administration is not feasible in these patients.
•Link to prescribing information:

•Prescribing information

Xenazine (tetrabenazine) by Prestwick Pharmaceuticals
Approval: treatment of chorea associated with Huntington’s disease (HD)
•Link to FDA Press Release:

•FDA press release 8/08

•Link to prescribing information:

•Prescribing information

Zolpimist (zolpidem oral spray) 5,10mg by Novadel
Approval: short-term treatment of insomnia characterized by difficulty with sleep initiation
•Link to press release:

•NovaDel press release 12/08

Sources:
U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA

U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER

[chantell.reagan]

One of our members informed us of some additional biologic approvals for 2008. Please note the following:

Kinrix (DTaP-IPV vaccine) by GlaxoSmithKiline
Approval: active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first three doses and INFANRIX for the fourth dose

•Link to prescribing information:Prescribing information

•Link to FDA letter: FDA letter

Novolog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection, (rDNA origin)) by NovoNordisk
Approval: adjunct to diet and exercise to improve glycemic control in patients with diabetes mellitus

•Link to prescribing information: Prescribing information

•Link to FDA letter: FDA letter

PegIntrol/Rebetol Combo Pack (Peg-interferon alfa-2b & ribavirin) by Schering-Plough
Approval: chronic hepatitis C

•Prescribing Information

Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine] (DTaP-IPV/Hib)) by Sanofi Pasteur
Approva: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b

•Link to prescribing information: Prescribing information

•Link to FDA Letter:FDA Letter

Rotarix (rotovirus vaccine, live) by Bioavail Pharmaceuticals
Approval: prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children

•Link to prescribing information: Prescribing information

•Link to FDA letter:FDA letter

Xyntha (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free) by Wyeth
Approval: control and prevention of bleeding episodes in patients with hemophilia and surgical prophylaxis in patients with hemophilia

•Link to prescribing information:Prescribing information

•Link to FDA letter: FDA letter

Sources:
U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA

U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER