Glenmark Pharmaceuticals Ltd has said that Glenmark Generics has been granted final approval for the Abbreviated New Drug Application (ANDA) by the US Food and Drug Administration (US FDA) for Nizatidine capsules and will start marketing immediately.
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.