Trade Resources Industry Views Watson Laboratories Received FDA Approval

Watson Laboratories Received FDA Approval

Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application for Vancomycin hydrochloride capsules, USP, 125mg and 250mg.

The company has begun the shipment of the product which is indicated for the treatment of C difficile-associated diarrhea and also for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).

The product is the generic version of ViroPharma's VANCOCIN HCl capsules.

According to IMS Health, VANCOCIN HCl capsules had total US sales of $332m for the twelve months ending 29 February 2012.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/watson-receives-fda-approval-for-vancomycin-hydrochloride-capsules-110412
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Watson receives FDA approval for Vancomycin hydrochloride capsules