Express Pharma

Glenmark receives ANDA approval for Colesevelam Hydrochloride

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The US FDA grants final ANDA approval for generic version of Welchol for oral suspension

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (US FDA) for Colesevelam Hydrochloride for oral suspension, 1.875 grams/Packet and 3.75 grams/Packet, the generic version of Welchol for oral suspension, 1.875 grams/Packet and 3.75 grams/Packet, of Daiichi Sankyo.

According to IQVIATM sales data for the 12 month period ending May 2018, Welchol for oral suspension, 1.875 grams/Packet and 3.75 grams/Packet achieved annual sales of approximately $73.0 million.

Glenmark’s current portfolio consists of 138 products authorized for distribution in the US marketplace and 62 ANDA’s pending approval with the US FDA. In addition to these internal filings, the company continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

 

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