Final US OK for Mylan's propranolol ER
The US Food and Drug Administration has granted final approval for Mylan Laboratories' Abbreviated New Drug Application for propranolol HCl extended-release capsules, USP in 60mg, 80mg, 120mg and 160mg strengths.
The ER capsules are the generic version of Wyeth Pharmaceutical's Inderal LA, which had US sales of approximately $201.0 million for the same strengths for the 12-month period ended December 31, 2006, according to IMS Health. Forest said it would begin shipping the product immediately.
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