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  1. FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cog
  2. FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Age
  3. FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in p
  4. FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder can
  5. FDA Drug Safety Communication: Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole
  6. FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of pro
  7. FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to redu
  8. FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blo
  9. FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containi
  10. Questions and Answers – Ongoing safety review of birth control pills containing drospirenone and a possible increased ri
  11. FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazon
  12. Postmarketing Drug Safety Evaluations
  13. FDA Drug Safety Communication: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri
  14. FDA Drug Safety Communication: FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs)
  15. FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young
  16. FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and cardiovascular events
  17. April 5, 2011 Approval Letter - Gardasil
  18. FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developin
  19. FDA Drug Safety Communication: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-
  20. FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexil
  21. FDA Drug Safety Communication: Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral
  22. FDA Drug Safety Communication: Liver injury warning to be removed from Letairis (ambrisentan) tablets
  23. FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate)
  24. FDA Drug Safety Communication: Safety Review update of Abacavir and possible increased risk of heart attack
  25. FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs
  26. FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor
  27. FDA Drug Safety Communication: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks
  28. FDA Drug Safety Communication: Severe liver injury associated with the use of dronedarone (marketed as Multaq)
  29. FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer
  30. FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible incre
  31. FDA Drug Safety Communication: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)
  32. FDA Drug Safety Communication: Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by chi
  33. FDA Drug Safety Communication: FDA recommends against the continued use of propoxyphene
  34. FDA reminder to avoid concomitant use of Plavix (clopidogrel) and omeprazole
  35. Safe Use Initiative: Acetaminophen Toxicity
  36. FDA Drug Safety Communication: Invirase (saquinavir) labels now contain updated risk information on abnormal heart rhyt
  37. FDA Drug Safety Communication: Update to Ongoing Safety Review of GnRH Agonists and Notification to Manufacturers of GnR
  38. FDA Drug Safety Communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures
  39. FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine)
  40. Safe Use Initiative: Opportunities for Collaboration
  41. FDA significantly restricts access to the diabetes drug Avandia
  42. FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Can
  43. FDA Drug Safety Communication: New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pedi
  44. FDA Statement on ASBMR report: Possible Increased Risk of Certain Types of Thigh Bone Fractures with Long-Term Bisphosph
  45. FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to
  46. URGENT - Voluntary Market Withdrawal of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation
  47. FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk
  48. FDA Drug Safety Communication: Aseptic meningitis associated with use of Lamictal (lamotrigine)
  49. FDA Drug Safety Communication: Serious medication errors from intravenous administration of nimodipine oral capsules
  50. FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of
  51. FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin)
  52. FluMist
  53. FDA Statement on Avandia TIDE Trial
  54. FDA Drug Safety Communication: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide)
  55. FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate)
  56. Tamiflu and Relenza Emergency Use Authorization Disposition Letters and Question and Answer Attachments
  57. Implementation of the Biologics Price Competition and Innovation Act of 2009
  58. FDA Drug Safety Communication: Ongoing safety review of Benicar and cardiovascular events
  59. FDA Drug Safety Communication: Drug labels now contain updated recommendations on the appropriate use of long-acting inh
  60. FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and severe liver injury
  61. FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton
  62. FDA Drug Safety Communication: Medication errors from swallowing topical Benadryl Extra Strength Itch Stopping Gel
  63. FDA Drug Safety Communication: Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certai
  64. FDA Drug Safety Communication: New Boxed Warning on severe liver injury with propylthiouracil
  65. FDA Drug Safety Communication: Update: Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Mono
  66. OxyContin - Questions and Answers
  67. FDA Drug Safety Communication: Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development
  68. FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fracture
  69. FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal hea
  70. FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Bet
  71. Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp
  72. Questions and Answers for Healthcare Professionals: CRESTOR and the JUPITER Trial
  73. Questions and Answers for Healthcare Professionals: CRESTOR and the JUPITER Trial
  74. FDA Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine)
  75. Current Drug Shortages
  76. FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (nataliz
  77. FDA Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine)
  78. Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia
  79. Follow-Up to the October 2008 Updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spir
  80. Follow-Up to the August 2008 Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vy
  81. Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval --
  82. Twinrix
  83. Approved Active Moieties That Have Appeared On The National Institutes Of Health’s (NIH) Annual Priority List For Which
  84. Early Communication about an Ongoing Safety Review of*Meridia (sibutramine hydrochloride)
  85. Information for Healthcare Professionals: Peramivir IV Renal Dosing Recommendations
  86. Follow-Up to the January 26, 2009, Early Communication about an Ongoing Safety Review of Clopidogrel Bisulfate (marketed
  87. Information for Healthcare Professionals: Update to the labeling of Clopidogrel Bisulfate (marketed as Plavix) to alert
  88. Information for Healthcare Professionals - Potential Contamination of Products Manufactured by Genzyme Corporation, Mark
  89. Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as By
  90. Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions
  91. Question and Answers about Changes to the USP Heparin Monograph
  92. Questions and Answers for Consumers about FDA’s Action Involving Unapproved Codeine Sulfate Tablets
  93. Information for Healthcare Professionals - Authorization of Use of Expired Tamiflu for Oral Suspension
  94. FDA Public Health Alert: Change in Heparin USP Monograph
  95. Emergency Use of Tamiflu in Infants Less than 1 Year of Age
  96. FDA Informs Consumers of a Nationwide Voluntary Recall of Certain Tylenol Products
  97. Early Communication about an Ongoing Safety Review of*Deferasirox (marketed as Exjade)
  98. Information for Healthcare Professionals - Acute pancreatitis and sitagliptin (marketed as Januvia and Janumet)
  99. FDA Public Health Alert: Potential Medication Errors with Tamiflu for Oral Suspension
  100. Information for Healthcare Professionals - Intravenous Promethazine and Severe Tissue Injury, Including Gangrene
  101. Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate),
  102. Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)
  103. Gardasil Vaccine Safety
  104. Information for Healthcare Professionals: Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Ci
  105. Information for Healthcare Professionals: OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (mar
  106. Information for Healthcare Professionals: New Safety Information for Colchicine (marketed as Colcrys)
  107. Influenza Virus Vaccine for the 2009-2010 Season
  108. Access to Iplex for Patients with ALS
  109. Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth
  110. Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)
  111. Questions and Answers about Onsolis (fentanyl buccal soluble film)
  112. Information for Healthcare Professionals: Immunosuppressant Drugs: Required Labeling Changes
  113. Facts and Myths about generic drugs
  114. Acetaminophen Information
  115. Propoxyphene Questions and Answers
  116. Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin
  117. Early Communication About Safety of Lantus (insulin glargine)
  118. Influenza (Flu) Antiviral Drugs and Related Information
  119. Information for Healthcare Professionals: Cefepime (marketed as Maxipime)
  120. Drugs to be Discontinued
  121. Information on Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size
  122. Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactiv
  123. Early Communications About Ongoing Safety Reviews
  124. Sirolimus (marketed as Rapamune)
  125. Agenda for the May 27 - 28, 2009 Opioid REMS Public Meeting
  126. Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution (updated)
  127. Drug Shortages: Current Drug Shortages: Isoniazid Injection (NDC 00781-3056-70)
  128. Drug Shortages: Current Drug Shortages: Methotrexate injection (updated)
  129. Drug Shortages: Current Drug Shortages: Dexrazoxane for Injection, Zinecard
  130. Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated)
  131. Drug Shortages: Resolved Drug Shortages: Fentanyl transdermal patch (updated)
  132. Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated)
  133. Risk evalation and Mitigation strategies (REMS)
  134. Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated)
  135. Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated)
  136. Testosterone Gel Safety Information
  137. Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets (updated)
  138. Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated)
  139. Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic
  140. Drug Shortages: Current Drug Shortages: Methotrexate injection
  141. FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic and Myobloc (
  142. Drug Shortages: Resolved Drug Shortages: Leucovorin Calcium Solution for Injection
  143. Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution (updated)
  144. Drug Shortages: Resolved Drug Shortages: Acyclovir Injection
  145. FDA updates action on Plan B (levonorgestrel) tablets
  146. Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets
  147. Drug Shortages: Resloved Drug Shortages: Acyclovir Injection
  148. Drug Shortages: Current Drug Shortages: Acyclovir Injection (updated)
  149. Efalizumab (marketed as Raptiva) Information
  150. Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution
  151. Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml
  152. Drug Shortages: Resolved Drug Shortages: Amikacin sulfate injection
  153. Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets
  154. FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs
  155. Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated)
  156. Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated)
  157. Drug Shortages: Current Drug Shortages: Leucovorin Calcium Solution for Injection (updated)
  158. FDA issues Information for Healthcare Professionals for Insulin Pens
  159. Drug Shortages: Current Drug Shortages: Triamcinolone Hexacetonide (Aristospan)
  160. Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets
  161. Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg)
  162. FDA issues Updated Safety Information about Raptiva (efalizumab).
  163. Drug Shortages: Resolved Drug Shortages: Alprostadil 0.5 mg/mL injection
  164. Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg)
  165. Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg)
  166. Drug Shortages: Current Drug Shortages: Amikacin sulfate injection
  167. Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection)
  168. Drug Shortages: Current Drug Shortages: Acyclovir Injection
  169. Drug Shortages: Current Drug Shortages: Calcium Disodium Versenate Injection 200 mg/mL 5 mL ampules(NDC 00089-0510-06)
  170. FDA issues an Early Communication about an Ongoing Safety Review Xigris (Drotrecogin alfa [activated])
  171. Drug shortage: Metoprolol succinate extended release tablets
  172. FDA issues an Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix)
  173. Drug Shortages: Current Drug Shortages; Leucovorin
  174. Re-labelling of OTC Cough & Cold medicine for pedi patients
  175. Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair)
  176. Follow-up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed a
  177. ETHEX and FDA notify heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets du
  178. FDA requires new safety measures for oral sodium phosphate products to reduce risk of acute kidney injury
  179. MedWatch item on antiepileptic drugs
  180. Drug Shortages: Current Drug Shortages; Alprostadil 0.5 mg/mL injection
  181. Drug Shortages: Resolved Drug Shortages; Methadone Hydrochloride Injection
  182. FDA issues questions and answers on medication guides for erythropoiesis-stimulating agents (ESAs)
  183. Information for Healthcare Professionals Phenytoin and Fosphenytoin Sodium
  184. Drug Shortages: Current Drug Shortages; Leucovorin
  185. Drug Shortages: Current Drug Shortages; Levoleucovorin (Fusilev) 50 mg single use vials
  186. Drug Shortages: Resolved Drug Shortages; Argatroban Injection
  187. FDA updates the Early Communication about the Ongoing Safety Review of Bisphosphonates
  188. September and November First-Time Generic Drug Approvals
  189. Drug Shortages: Current Drug Shortages; Argatroban Injection
  190. Drug Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection
  191. Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules
  192. FDA issues warning letters to Bayer HealthCare for illegally marketing two unapproved drugs
  193. Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension
  194. Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection
  195. Ethex Corp and FDA notify healthcare professionals of a voluntary recall of three lots of dextroamphetamine sulfate 5mg
  196. FDA issues an updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler).
  197. Warning Letter
  198. On September 26th, FDA approves Alimta (pemetrexed) injection for use in combination with cisplatin therapy for the init
  199. Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland
  200. List of Authorized Generic Drugs
  201. Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection
  202. Warning and Untitled Letters
  203. List of Authorized Generic Drugs
  204. Epoetin alfa - Early Communication about an Ongoing Safety Review
  205. Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
  206. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated
  207. A List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd.
  208. Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated
  209. FDA orders companies to stop marketing unapproved ophthalmic balanced salt solutions (BSS)
  210. FDA orders companies to stop marketing unapproved drug products that contain papain in a topical dosage form
  211. List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd.
  212. Covidien and Mallinckrodt Inc. inform healthcare professionals of important new safety information in prescribing Phosph
  213. Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10%
  214. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection)
  215. FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India.
  216. Genentech announces revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoenc
  217. Warning Letter: Bystolic (nebivolol) Tablets
  218. Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)
  219. FDA posts quarterly report of potential safety issues.
  220. Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS): Janua
  221. Adverse Event Reporting System (AERS) (updated)
  222. FDA announces that manufacturers of TNF-blocker drugs must highlight the risk of fungal and serious opportunistic infect
  223. August First-Time Generic Drug Approvals
  224. What You Should Know about Prescription Drug Advertisements
  225. Natural Disaster Response
  226. FDA updates the Information for Healthcare Professionals sheet for Tysabri (natalizumab)
  227. Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection
  228. FDA issues an Early Communication About an Ongoing Safety Review of Vytorin, Zocor, and Zetia.
  229. Drug Safety Oversight Board Meeting
  230. Generic Drug Petition Tracking: Suitability Tracking Reports
  231. Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
  232. FDA updates the Information for Healthcare Professionals sheet for Byetta (exenatide)
  233. Watson Pharmaceuticals, Inc. issues a voluntary recall of one lot of 75mcg/hr Fentanyl Transdermal System patches
  234. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution
  235. Pediatric Research Equity Act (PREA) Labeling Changes
  236. FDA issues an Information for Healthcare Professionals sheet for Amiodarone and Simvastatin.
  237. Drug Firm Annual Registration Status
  238. Cyber Letters
  239. National Drug Code Directory
  240. Drug Approval Reports: NDA and BLA Approvals
  241. Drug Approval Reports: Priority NDA and BLA Approvals
  242. Drug Approval Reports: NME Drug and New Biologic Approvals
  243. Month First-Time Generic Drug Approvals
  244. CDER 2007 Update: Improving Public Health Through Human Drugs.
  245. CDER Update 2007: Improving Public Health Through Human Drugs.
  246. Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels
  247. Postmarketing Study Commitments Database
  248. FDA issues Complete Response letters ordering Safety Labeling Changes under FDAAA for Aranesp, Epogen, and Procrit
  249. MedWatch Safety Alert for mitoxantrone
  250. Drug Safety Oversight Board Meeting, June 19, 2008