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FDA Approves Par’s Generic Version of Trandate

July 18, 2012, 9:34 PM

Par Pharmaceutical Cos. July 13 announced that its subsidiary, Par Formulations Private Ltd., has received its first Food and Drug Administration approval, for a generic version of Prometheus Laboratories’ Trandate (labetalol hydrochloride) 100 milligram, 200 mg, and 300 mg tablets.

Trandate is indicated for managing hypertension, the company said. The drug may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

Par, which is based in Woodcliff Lake, N.J., said it anticipates its generic product will be available in August. Par Formulations previously was known as Edict Pharmaceuticals Private Ltd., and is based in ...