Alembic Pharma gets tentative USFDA nod for generic cancer drug; may secure 180-day exclusivity
Alembic Pharmaceuticals Ltd. received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of Larotrectinib Capsules in strengths of 25 mg and 100 mg, the company said in an exchange filing on Thursday, June 11. The approved abbreviated new drug application (ANDA) is therapeutically equivalent to Bayer Healthcare Pharmaceuticals’ Vitrakvi…
