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USFDA approves Glenmark Pharmaceuticals Propafenone Hydrochloride Extended-Release Capsules

 

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Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 mg, the generic version of Rythmol SR® Capsules, 225 mg, 325 mg, and 425 mg, of GlaxoSmithKline, LLC.

According to IMS Health sales data for the 12 month period ending July 2017, the Rythmol SR® Capsules, 225 mg, 325 mg, and 425 mg market1 achieved annual sales of approximately $69.2 million*.

 

Glenmark’s current portfolio consists of 123 products authorized for distribution in the U.S. marketplace and 63 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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