FDA has approved generic vancomycin capsules of 125 mg and 250 mg manufactured by Strides. Vancomycin is a glycopeptide antibiotic used in the prophylaxis and treatment of infections caused by Gram-positive bacteria. It has traditionally been reserved as a drug of ‘last resort’, used only after treatment with other antibiotics had failed.

According to IMS Health data, vancomycin capsules had total US sales of US$332 million for the twelve months ending 12 February 2012.

Although several generics companies including APP Pharmaceuticals, Hospira and Sandoz, have FDA approval for injectable vancomycin, this is the first generics approval for the capsules according to Strides Arcolab. Strides CEO Mr Arun Kumar stated that ‘oral vancomycin development is one among the many value generics programmes being undertaken at the Strides Group with a special focus to develop niche and difficult to manufacture products.’

The product will be launched immediately through Alvogen on a profit share basis, the company said.

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