Watson gains two generic approvals
PARSIPPANY, N.J. — Watson Pharmaceuticals announced that its subsidiary, Watson Laboratories, has received Food and Drug Administration approval on its abbreviated new drug application for irbesartan tablets — the generic equivalent to Sanofi's Avapro — in the 75-mg, 150-mg and 300-mg strengths.
Avapro is indicated for the treatment of hypertension when used alone or in combination with other antihypertensive agents. It is also indicated for the treatment of diabetic nephropathy. Avapro and its generic equivalents had total U.S. sales of approximately $390 million for the 12 months ended Aug. 31, 2012, according to IMS Health data.
Watson Laboratories also received FDA approval on its abbreviated new drug application for trospium chloride extended-release capsules, the generic equivalent to Allergan's Sanctura XR. For the 12 months ended July 31, 2012, Sanctura XR had total U.S. sales of approximately $67 million, according to IMS Health.
The company plans to begin shipping both products immediately.