Watson Pharmaceuticals’ arm gets nod from U.S. FDA for Azurette Tablets

Watson Pharmaceuticals, Inc. has notified that its unit, Watson Laboratories, Inc. has received final nod from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP, 0.15 mg / 0.02 mg. The latest drug is the generic equivalent to Duramed Pharmaceuticals’ Mircette(R) low-dose monthly oral contraceptive product, which is indicated for prevention of pregnancy. California-based pharmaceutical firm intends to launch the product in early January 2009 under the trade name Azurette (TM).

FDA approval for Watson’s RAPAFLO

The U.S. Food and Drug Administration has given the approval to Watson Pharmaceuticals, Inc.’s RAPAFLO(TM) (silodosin), the novel alpha blocker to be used for treating the symptoms of Benign Prostatic Hyperplasia (BPH). The disorder is characterized by prostate problems such as decline in urine flow, nocturia and frequent urination. RAPAFLO binds to the alpha (1A) receptors, with high affinity, that are concentrated in the prostate. This smoothens the muscles in these tissues. As they get to relax, urine flow improves.