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WOODCLIFF LAKE, N.J. — A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.
Par said Par Formulations received approval from the FDA for labetalol hydrochloride tablets in the 100-mg, 200-mg and 300-mg strengths. The drug, a generic version of Prometheus Labs' Trandate, is used to treat hypertension.
Par acquired Par Formulations, formerly the Chennai, India-based drug maker Edict Pharmaceuticals, in February 2012.