Teva receives FDA Approval for Generic Sarafem Pulvules

Posted by JaneMorrison
Thu, 06/05/2008 - 14:20

Pharmaceutical Industries Ltd. (TEVA) said that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application for Fluoxetine Capsules USP, 10 mg and 20 mg.

Shipment of the product will begin immediately. Teva has been awarded a 180-day period of marketing exclusivity.

Teva's Fluoxetine Capsules are the AB-rated generic equivalent of Eli Lilly's Sarafem Pulvules, and are indicated for the treatment of premenstrual dysphoric disorder.

According to IMS sales data, the brand product had annual sales of about $39 million in the United States for the twelve months that ended March 31, 2008.

 


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