FDA Gives Teva Generic Prozac OK

Israeli drug maker Teva Pharmaceutical Industries Ltd. said Sunday it received tentative approval from the Food and Drug Administration for the antidepressant fluoxetine, the generic version of Eli Lilly & Co.’s Prozac.

The tentative approval of Teva’s 10 milligram tablets comes after similar FDA tentative approval of Teva’s 10 mg and 20 mg capsules last year.

Pharmaceutical Resources Inc. said last week that it intends to market fluoxetine and believes it would receive the 180 days of exclusivity as marketer of certain forms of the drug. Barr Laboratories Inc. said it plans to begin selling a generic version of Prozac on Aug. 2.

The FDA typically grants six months of exclusive marketing rights to the first company that files for approval to sell a generic version of a drug.

Last week, a three-judge panel of the federal appeals court in Washington upheld a decision invalidating a Lilly patent that would have prevented generic versions of Prozac until December 2003.

Prozac sales totaled about $2.6 billion in 2000, about a quarter of Lilly’s total sales. But Lilly’s schizophrenia drug Zyprexa overtook Prozac as the Indianapolis-based drug maker’s best-selling prescription drug.