TEVA RECEIVES APPROVAL FOR GLIMEPIRIDE; SANOFI LAUNCHES GENERIC VERSION

Teva Pharmaceutical has received approval from the FDA to launch a generic version of sanofi-aventis' diabetes treatment Amaryl (glimepiride), but Teva will not have the market to itself, as sanofi-aventis has already moved to launch an authorized generic.

The FDA recently granted final approval to Teva's abbreviated new drug application for glimepiride in 1-, 2- and 4-mg tablets. Teva plans to begin shipping the product immediately.

Teva is already facing competition from sanofi-aventis, which has partnered with Prasco Laboratories to launch a branded generic version of Amaryl. Prasco has already started shipping the authorized generic, which is being offered in Amaryl's unique butterfly-shaped tablets.

Amaryl is indicated to help lower glucose in Type II diabetes patients whose hyperglycemia cannot be controlled by diet and exercise alone. The drug generates annual U.S. sales of roughly $350 million.