Glenmark gets tentative nod for Gabapentin Enacarbil Extended-Release Tablets, Apremilast Tablets

31 Dec 2020 Evaluate

Glenmark Pharmaceuticals has received tentative approval by the United States Food & Drug Administration (USFDA) for Gabapentin Enacarbil Extended-Release Tablets, 300 mg and 600 mg, the generic version of Horizant Extended-Release Tablets, 300 mg and 600 mg, of Arbor Pharmaceuticals, LLC. The Horizant market achieved annual sales of approximately $99.5 million.

Additionally, the company has received tentative approval for Apremilast Tablets, 10 mg, 20 mg and 30 mg, the generic version of Otezla Tablets, 10 mg, 20 mg and 30 mg, of Amgen, Inc. The Otezla Tablets, 10 mg, 20 mg and 30 mg market achieved annual sales of approximately $2.7 billion.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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