Glenmark Pharma gets US FDA Final Approval For Nizatidine Capsules

Glenmark Pharmaceuticals Ltd. announced today that its subsidiary Glenmark Generics had been granted final approval for its abbreviated new rrug application (ANDA) by the US FDA for Nizatidine Capsules.

Nizatidine capsules are Glenmark's generic version of Axid by SmithKline Beecham Corporation and are indicated for up to 8 weeks for the treatment of active duodenal ulcer, the company said in a statement.

The company said it would commence marketing immediately.

Last week Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, got the final approval for its abbreviated new drug application by the US FDA for Ursodiol tablets USP, which had US market sales of $60 million last year.

Ursodiol is the generic version of Urso 250 and Urso Forte tablets by Axcan.