FDA approves Mylan sleep medication

6/17/2009

PITTSBURGH The Food and Drug Administration has approved an additional strength of Mylan’s generic version of a sleeping drug, Mylan announced Wednesday.

The Pittsburgh-based drug maker said the FDA had approved its temazepam capsules in the 22.5-mg strength and that shipment of the product had begun. The company already markets the drug in the 15-mg and 30-mg strengths.

The capsules are a generic version of Mallinckrodt’s Restoril, which had sales of $6 million for the 12 months ended March 31, according to IMS Health data.

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