Wockhardt gets US FDA nod to market Ceftazidime injections
16 Oct 2008
US FDA approves Wockhardt's generic version of GSK's Fortaz
MimbaIi-based Wockhardt will launching Ceftazidime injection in the United States, following approval from the US FDA for marketing the injections containing 1 gm / vial Ceftazidime, used for the treatment of infections.
Ceftazidime is the generic name for the brand Fortaz, sold in the US by Glaxo Smithkline.
''Wockhardt is one of the only three companies to have received this approval'' said Wockhardt chairman Habil Khorakiwala. ''This product required significant R&D activity in both API and injections and is a reflection of the multi-faceted capabilities of Wockhardt to meet the challenges of the US markets.''
The company ssaid its ceftazidime injections will be launched in the US shortly. According to IMS, the total market for Ceftazidime injections in the US is $42 million, of which the 1gm market has sales worth $12.6 million.
wockhardt says Ceftazidime is used in the treatment of several kinds of infections and is one of the most potent, powerful and safe antibiotics.
The Ceftazidime pentahydrate API is manufactured in the FDA approved API facility at Ankleshwar, Gujarat and the injections are manufactured at the US FDA certified formulation plant at Waluj, Maharashtra. The API and the product were developed in-house.
Wockhardt has 11 approvals from the US FDA for its sterile products including Cephalosporins. In the prescription generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. Wockhardt today markets over fifty five products in the US.