Therapy Areas: Central Nervous System
US FDA Approves Amneal ANDA for Generic Carafate
6 December 2019 - - US-based pharmaceutical company Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has received final US Food and Drug Administration approval on its Abbreviated New Drug Application for a generic version of Carafate (sucralfate) Oral Suspension, 1 g/10 ml, the company said.

Amneal said it has immediately initiated commercialisation activities.

According to IQVIA, U.S market annual sales for the 12 months ended October 31, 2019, for sucralfate oral suspension was estimated to be approximately USD 285m.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is an integrated pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.

The company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has a portfolio of more than 300 generic medicines and is expanding its portfolio to include complex dosage forms in a range of therapeutic areas.

The company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system disorders, endocrinology and parasitic infections.


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