FDA approved Glenmark’s generic drug

| By | Drug Quality Control, FDA, Glenmark

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (FDA) for fenofibrate capsules USP, 67 mg, 134 mg and 200 mg, the generic version of Tricor Micronized capsules, 67 mg, 134 mg, and 200 mg of AbbVie, Inc.

According to IMS Health sales data for the 12 month period ending February 2017, the Tricor Micronized capsules, 67 mg, 134 mg and 200 mg market achieved annual sales of approximately $97.5 million.

Glenmark’s current portfolio consists of 114 products authorized for distribution in the US marketplace and approximately 64 ANDA’s pending approval with the US 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.

Glenmark Pharmaceuticals Ltd. is a global innovative pharmaceutical company with operations in more than 80 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of oncology, respiratory disease, and dermatology.

SOURCE: pharmabiz
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