New FDA Approvals
FDA recently approved these drugs:
• Over-the-counter access to Barr Pharmaceuticals' Plan B emergency contraceptive was approved for women ages 18 and older. It remains a prescription-only product for those ages 17 and younger. The company will make Plan B available with a rigorous labeling, packaging, education, distribution, and monitoring program known as CARE (Convenient Access, Responsible Education).
• A new medical use has been approved for Sanofi-Aventis' Plavix (clopidogrel bisulfate) for patients who have had an acute ST-segment elevation myocardial infarction (STEMI) and are not going to have angioplasty. In STEMI patients, FDA said, clopidogrel prevents subsequent blockage in the already-damaged heart vessel that could lead to more heart attacks, stroke, and possibly death. Clopidogrel was first approved in November 1997 to decrease platelet function in people who suffer from acute coronary syndrome.
• Generic versions of Bayer's Cipro IV (cipro-floxacin injection) and Wyeth's Effexor (venlafaxine) were approved. Several companies received approval for generic ciprofloxacin, indicated for treating certain bacterial infections, including urinary tract infections, lower respiratory tract infections, bone and joint infections, complicated intraabdominal infections, skin and skin structure infections, and therapy of patients with fever and neutropenia. Teva Pharmaceuticals USA will manufacture and distribute generic venlafaxine tablets 25 mg, 37.5 mg, 50 mg, 75 mg, and 100 mg. It is indicated for treating major depressive disorder and will carry the same labeling, including a black box warning, as the branded drug. Teva received 180 days of marketing exclusivity for its generic.
FDA recently approved these drugs: Over-the-counter access to Barr Pharmaceuticals' Plan B emergency contraceptive was approved for women ages 18 and older. It remains a prescription-only product for those ages 17 and younger.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.