Wockhardt gets USFDA approval for insomnia drug sale
14 Nov 2008
Mumbai: Pharmaceutical major Wockhardt has received approval from the US Food and Drug Administration (US FDA) for marketing Midazolam injections, a drug used in the treatment of sleeplessness and anxiety.
The FDA approval allows Wockhardt to market preservative-free version injections containing 1mg/ ml and 5 mg/ml Midazolam in the US, the company said in a filing with the Bombay Stock Exchange.
Developed in-house, the injections are manufactured at the US FDA certified formulation plant at Waluj, Maharashtra, the company said in its release.
''Sterile products continue to be a priority area for Wockhardt in the US,'' said company chairman Habil Khorakiwala.
''This is our fourth injection `Abbreviated New Drug Application' approval in two months and the 12th sterile product overall,'' he added.
Wockhardt had earlier received US FDA approval for the injection containing preservatives. Midazolam is the generic name for the brand Versed.
Midazolam injections in the the US had total market for $56 million, according to IMS.
Wockhardt has consistently been growing market shares for all its products in the prescription generic pharmaceutical market. Wockhardt today markets over fifty-five products in the US.
