New FDA Approvals
October 1, 2002 less than 1 minute read
The following drugs have received final approval from the Food and Drug Administration (FDA):
- Valsartan (Diovan) by Novartis Pharmaceuticals. The FDA has approved valsartan (Diovan) to treat heart failure in patients who are intolerant of angiotensin-converting-enzyme inhibitors. Valsartan, an angiotensin II receptor blocker, is the first drug in its class to obtain an indication beyond hypertension.
- 1% clindamycin and 5% benzoyl peroxide topical gel (Duac) by Stiefel Laboratories. The FDA has approved a ready-to-dispense topical gel containing 1% clindamycin and 5% benzoyl peroxide for once-daily treatment of inflammatory acne vulgaris.
- Anastrozole (Arimidex) by AstraZeneca. The FDA has approved anastrozole (Arimidex) for the adjuvant treatment of hormone-receptor positive early breast cancer in postmenopausal women. Anastrozole is the only hormonal drug other than tamosifen approved for this indication. The drug was originally approved in 1996 for treatment of hormone-receptor positive advanced breast cancer in postmenopausal women. In 2000, it was also approved for first-line treatment of hormone-receptor positive advanced breast cancer in postmenopausal women.
- Escitalopram oxalate (Lexapro) by Forest Laboratories. The FDA has approved escitalopram oxalate (Lexapro) for the treatment of major depressive disorder, as well as maintenance treatment for patients with major depressive disorder. Escitalopram oxalate, a selective serotonin reuptake inhibitor, is the single-isomer of citalopram HBr (Celexa).
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