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Glenmark receives US FDA approval for generic Mycolog-II cream USP, one lac units per g, One percent

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Glenmark receives US FDA approval for generic Mycolog-II cream USP, one lac units per g, One percent

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (FDA) for nystatin and triamcinolone acetonide cream USP, 100,000 units/gram and 1 mg/g, the generic version of Mycolog-II (nystatin and triamcinolone acetonide) cream, 100,000 units/g, 0.1%, of Delcor Asset Corporation (which is no longer being marketed in the United States).

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Description

  • According to IMS Health sales data for the 12 month period ending August 2016, the Mycolog-II (nystatin and triamcinolone acetonide) cream, 100,000 units/g, 0.1% market achieved annual sales of approximately $120.9 million.
  • Glenmark’s current portfolio consists of 111 products authorized for distribution in the US marketplace and 60 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.

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Glenmark, us fda, approval, generic, mycolog ii, cream usp

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