Pharmabiz
 

Wockhardt gets US FDA nod to market Sumatriptan injections in US for migraine

Our Bureau, MumbaiWednesday, February 18, 2009, 08:00 Hrs  [IST]

Pharmaceutical and biotechnology major, Wockhardt will soon be launching Sumatriptan injections in the United States. Wockhardt received the final approval from the United States Food & Drug Administration (US FDA) for marketing the injections containing 6mg per 0.5m1 Sumatriptan succinate, which is used for treating migraine headaches. Sumatriptan, is the generic name for the brand Imitrex marketed in the United States by GlaxoSmithkline. According to IMS, the total market for Sumatriptan injections in the US is worth $255 million, of which the vials had sales of $27 million. Wockhardt's Sumatriptan injections will be launched in the US shortly. The patent on Sumatriptan expired on February 6, 2009 and Wockhardt received the final approval for the product, on the day of patent expiration. Sumatriptan injections will be manufactured at the US FDA certified formulation plant at Waluj, Maharashtra. The product was developed in-house. "Injections and other sterile products form on integral pad of Wockhardt's growth strategy in the United States," said Wockhardt chairman Habil Khorakiwaia. "Sumatriptan injection is the thirteenth sterile product approval for Wockhardt and with a portfolio that includes various sterile dose forms such as solutions, suspensions, powders and specialised delivery systems, Wockhardt's injections are now used in many clinics and hospitals across the US," he mentioned. Wockhardt is one of the top 5 companies in the world to have received the highest number of 23 Abbreviated New Drug Approvals (ANDA) by the US FDA for 2008. Wockhardt is a technology-driven global pharmaceutical and biotechnology major with an innovative multi-disciplinary research and development programme.

 
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