Drug filing/approvals

Watson Files ANDA for Generic Lybrel (Levonorgestrel and Ethinyl Estradiol)
Watson Pharma confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the USFDA seeking approval to market its Levonorgestrel and Ethinyl Estradiol tablets, USP (0.09 mg/0.02 mg) extended-cycle oral contraceptive product prior to the expiration of patents owned by Wyeth. Watson's Levonorgestrel and Ethinyl Estradiol product is a generic version of Wyeth's LYBREL(R) (levonorgestrel and ethinyl estradiol) tablets, which is indicated for the prevention of pregnancy.
Wyeth filed suit against Watson on March 12, 2008 in the U.S. District Court, District of Delaware, seeking to prevent Watson from commercializing its product prior to the expiration of US6500814.
Hawthorn Receives FDA Approval on Granisol Oral Solution
Hawthorn Pharmaceuticals, Inc. announced today the US Food and Drug Administration (FDA) approval of the company's Granisol(TM) (granisetron HCl) Oral Solution. Granisol(TM) is an oral solution for the prevention of nausea and vomiting associated with cancer therapy. Granisol(TM) is the AA-rated equivalent of Roche's Kytril(R) Oral Solution. Granisol(TM) Oral Solution is available through all the national drug wholesalers as well as multiple other distribution channels and will begin shipping immediately. Granisol(TM) Oral Solution is available by prescription only in the United States.