Glenmark, Zydus get US go-ahead for Meloxicam

Domestic pharma companies Glenmark Pharmaceuticals and the Ahmedabad-based Zydus Cadila have received US Food and Drug Administration's approval to market Meloxicam oral tablets 7.5 mg and 15 mg in the US market.

The product is a generic version of Boehringer Ingelheim's brand"� Mobic, a non-steroidal anti-inflammatory drug (NSAID) and is prescribed for the treatment of osteoarthritis.

The size of the US market for this drug is about $1.2 billion as per the 2005 sales.

While Zydus Cadila has already introduced this product in the US on July 19, through its US subsidiary"�Zydus Pharmaceuticals (USA) Inc, Glenmark's US subsidiary, Glenmark Pharmaceutical Inc will be launching it in the market shortly.

Glenmark is manufacturing the drug at its solid-oral formulation facility at Goa. This was the third abbreviated new drug application (ANDA) filed by Glenmark from the Goa facility that has received US FDA approval after Fluconazole and Zonisamide.

Glenmark currently markets seven products in the US with the last launched product being Codeine Phosphate.

For Zydus, it marks the 16th ANDA approval in the US since the commencement of filing process in FY 2003-04. So far, the group has filed 37 ANDAs and 40 drug master files (DMFs) in the US.