08 August 2016 | News | By BioSpectrum Bureau
Glenmark receives ANDA approval for Nystatin, Triamcinolone Acetonide ointment
Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/1 mg per gram, the generic version of Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/1 mg per gram of Taro Pharmaceuticals.
According to IMS Health sales data for the 12 month period ending April 2016, the Nystatin and Triamcinolone Acetonide Ointment USP market1 achieved annual sales of approximately $37.5 million.
Glenmark's current portfolio consists of 114 products authorized for distribution in the US marketplace and 62 ANDA's pending approval with the USFDA. 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.