Shilpa Medicare bags USFDA approval for Varenicline Tablets for smoking cessation
Karnataka: Shilpa Medicare Limited has received approval from the US Food and Drugs Administration (USFDA) for Varenicline Tablets, 0.5 and 1 mg.
The total US market for this product is around 203 M USD.
Shilpa’s product has been approved as a generic version to the innovator - Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V.
Varenicline Tablets are indicated for smoking cessation; it helps people to quit smoking.
Medical Dialogue team had earlier reported that Shilpa Medicare's marketing partner, Amneal Pharmaceuticals, had launched BORUZU, (Bortezomib for injection 3.5mg/1.4ml), a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration.
Read also: Shilpa Medicare marketing partner Amneal Pharma unveils multiple myeloma treatment Boruzu
Read also: Shilpa Medicare Gets CDSCO Panel Nod for Novel NAFLD Drug, Advances to Marketing Approval Stage
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