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Home : Unsafe Drugs : Avandia : FDA Information : CDER News Items 2007 CDER News Items 2007
CDER News Items 2007
• October 10. FDA approves the first generic versions of Trileptal (oxcarbazepine), an anticonvulsant drug. • October 4. FDA announces an initiative to bolster its generic drug program. • October 4. FDA announces the award of a contract to assist with the transformation of FDA's Center for Drug Evaluation and Research. FDA News • October 3. FDA acts to ensure that thyroid drugs don’t lose their potency before the expiration date. Levothyroxine Information • October 1. FDA issues an Early Communication of an Ongoing Safety Review for bisphosphonates. • September 28. Manufacturers of gadolinium-based contrast agents for magnetic resonance imaging issue a Dear Healthcare Professional Letter. • September 28. The Food and Drug Administration Amendments Act of 2007 is signed into law. Information; The Act • September 28. FDA takes action to stop marketing of unapproved hydrocodone products. Enforcement information • September 26. FDA issues a Public Health Advisory and Healthcare Professional Sheet for Fentora (fentanyl buccal tablets). Drug Information • September 24. TWC Global LLC, Inc., issues a recall of Axcil and Desirin, both marketed as dietary supplements, because they contain undeclared analogs of sildenafil. MedWatch Safety Information • September 18. FDA launches the first issue of the FDA Drug Safety Newsletter, a publication for healthcare professionals and the medical community. • September 17. FDA issues an Alert on the risk of QT prolongation and Torsades de Pointes (TdP) in patients treated with Haldol (haloperidol). Drug Information • September 14. FDA approves Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. FDA News • September 11. FDA issues an FDA Alert and Healthcare Professional sheet for Rocephin (ceftriaxone) clarifying concomitant use with calcium-containing products or solutions. Drug Information • September 10. Pfizer issues a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate in Viracept (nelfinavir mesylate). MedWatch Safety Information • September 6. FDA approves the first generic versions of Coreg (carvedilol). FDA News • August 30. FDA approves Somatuline Depot (lanreotide acetate injection) for the treatment of acromegaly. FDA News • August 23. FDA proposes a new rule for sunscreen products to include a new UVA rating system and sun warning information. FDA News • August 22. FDA approves Risperdal (risperidone) for two psychiatric conditions in children and adolescents. FDA News • August 17. FDA issues an FDA Alert, Public Health Advisory, and Information for Healthcare Professional sheet on the use of codeine products in nursing mothers. Drug Information • August 16. FDA approves updated warfarin (marketed as Coumadin) prescribing information. FDA News • August 14. FDA announces that manufacturers of some diabetes drugs have strengthened the warning on heart failure risk. FDA News • August 14. Abbott Laboratories sends a Dear Healthcare Provider Letter to physicians and pharmacists that prescribe or distribute Kaletra Oral Solution. MedWatch Safety Information • August 9. FDA warns consumers to avoid Red Yeast Rice Products promoted on the Internet as treatments for high cholesterol. FDA News • August 9. FDA issues an Early Communication About an Ongoing Safety Review for Omeprazole (Prilosec) and Esomeprazole (Nexium). • August 7. FDA approves Selzentry (maraviroc), an antiretroviral drug for use in adult HIV patients. FDA News • July 27. FDA permits restricted use of Zelnorm (tegaserod maleate) for qualifying patients. FDA News • July 5. FDA approves the first generic versions of prescription Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis). FDA News • July 2. FDA issues a safety alert for omalizumab (marketed as Xolair). Omalizumab Information • June 28. FDA issues a Public Health Alert and Healthcare Professional Sheet for Colistimethate. Drug Information • June 22. FDA approves Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems. FDA News • June 18. FDA approves Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension. FDA News • June 15. FDA issues a safety alert for propofol (marketed as Diprivan and as generic products). Propofol Information • June 15. Confidence, Inc. recalls Long Weekend, a product sold as a dietary supplement, because it contains undeclared tadalafil. MedWatch Safety Information • June 1. FDA warns consumers to avoid using tubes of toothpaste labeled as made in China. FDA News • May 31. FDA approves Torisel (temsirolimus) for the treatment of renal cell carcinoma. FDA News • May 25. FDA takes action to stop the marketing of unapproved timed-release guaifenesin drug products. Information • May 22. Novartis and FDA notify healthcare professionals of changes the labeling for Exjade (deferasorix), a drug used to treat chronic iron overload. MedWatch Safety Information • May 21. Spectrum and FDA inform healthcare professionals of a nationwide recall of 3 lots of Caffeine Citrated, Powder, Purified. MedWatch Safety Information • May 10. FDA approves Neupro (rotigotine transdermal system), a skin patch designed to treat symptoms of early Parkinson's disease. FDA News • May 2. ApothéCure and FDA notify all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine. MedWatch Safety Information • May 2. FDA proposes new warnings about suicidal thinking and behavior in young adults who take antidepressant medications. FDA News • April 23. FDA approves first-time generic zolpidem tartrate tablets for short-term treatment of insomnia. The reference listed drug is Ambien. FDA News • April 23. FDA and Genentech inform healthcare professionals about tracheoesophageal fistula that occurred in a study combining concurrent chemotherapy and radiation plus Avastin in patients with limited-stage small cell lung cancer. MedWatch Safety Information • April 23. FDA announces audio broadcasts on emerging drug safety information. FDA News • April 13. FDA will hold a public hearing on the medication guide program with the goal of improving risk communication. FDA News • April 13. FDA approves Altabax (retapamulin ointment) for topical treatment of impetigo, a skin infection caused by bacteria. FDA News • April 11. Acorda Therapeutics and FDA inform healthcare professionals of changes to the product labeling for Zanaflex, a drug used to treat spasticity. MedWatch Safety Information • April 6. FDA announces that companies must stop marketing suppository products containing trimethobenzamide. FDA News • April 2. FDA approves first-time generic nadolol/ endroflumethiazide tablets to treat hypertension. The reference listed drug is Corzide. • March 30. Novartis Pharmaceuticals has agreed to FDA’s request that they voluntarily discontinue marketing and sales of Zelnorm (tegaserod maleate). Zelnorm information | Podcast • March 29. FDA announces a voluntary withdrawal of Permax and generic pergolide products which are used to treat Parkinson’s disease. Pergolide Information | Podcast • March 29. FDA launches a web page warning against buying Accutane and its generic versions online. FDA News • March 19. Cosmos Trading, Inc. and FDA notify consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name Rhino Max. MedWatch Safety Information • March 16. FDA approves Soliris (eculizumab), the first product for the treatment of paroxysmal nocturnal hemoglobinuria. FDA News • March 16. FDA issues an FDA Alert and Healthcare Professional Sheet on new emerging safety concerns about Zyvox (linezolid) from a recent clinical study. Zyvox Info • March 14. FDA requests label change for all sleep disorder drug products. Sedative-Hypnotics Information • March 13. FDA approves Tykerb (lapatinib) for advanced breast cancer patients. FDA News • March 9. FDA issues a Public Health Advisory and Healthcare Professional Sheet for Actimmune (interferon gamma-1b). Actimmune Info | Podcast • March 9. FDA strengthens safety information for erythropoiesis-stimulating agents (ESAs), widely-used drugs for the treatment of anemia. ESA Information | Podcast • March 9. Takeda and FDA notify healthcare professionals to consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with pioglitazone products. MedWatch Safety Information • March 6. FDA approves Tekturna (aliskiren) tablets, a new molecular entity, for the treatment of high blood pressure, or hypertension. FDA News • March 1. FDA publishes a final guidance on communicating drug safety information to the public. • March 1. FDA takes action to halt marketing of unapproved ergotamine. FDA News • February 27. FDA approves Humira (adalimumab) to treat adult patients with moderately to severely active Crohn's disease. FDA News • February 26. FDA and Bristol-Myers Squibb notify healthcare professionals of revisions to the labeling for Baraclude (entecavir). MedWatch Safety Information • February 23. Roche and FDA notify healthcare professionals that a clinical study on CellCept (mycophenolate mofetil) was terminated. MedWatch Information • February 21. FDA directs ADHD drug manufacturers to notify patients about cardiovascular adverse events and psychiatric adverse events. ADHD Information • February 21. FDA issues an FDA Alert and Healthcare Professional Sheet for Xolair (omalizumab) Xolair Information • February 20. Glaxo SmithKline notifies healthcare professionals to consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone. MedWatch Info • February 16. FDA updates the Alert and Healthcare Professional Sheet on Erythropoiesis Stimulating Agents (ESA) (marketed as Procrit, Epogen, and Aranesp). Drug Information • February 12. FDA and Sanofi-aventis agree on an updated label for Ketek (telithromycin), an antibiotic, and to distribute a Medication Guide for patients. Ketek Information • February 7. FDA approves Orlistat capsules as an over-the-counter (OTC) weight loss aid for overweight adults. Orlistat OTC Information • February 6. FDA issues Public Health Advisory on life-threatening side effects with the use of skin products containing numbing ingredients for cosmetic procedures. Advisory | Podcast • January 30. FDA outlines a comprehensive commitment to the safety of drugs and other medical products. FDA News FDA's "The Future of Drug Safety" report • January 29. FDA approves first-time generic dexmethylphenidate to treat attention deficit hyperactivity disorder (ADHD). The reference listed drug is Focalin Tablets. • January 26. Amgen releases the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy. MedWatch Safety Information • January 11. FDA proposes new measures to strengthen drug safety under the PDUFA reauthorized user fee program. FDA News News Items 2006 Avandia Case Evaluation Form
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