Alembic Pharma announces USFDA Tentative Approval for Larotrectinib Capsules, 25 mg and 100 mg.
Mumbai, 12th June 2026: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Larotrectinib Capsules, 25 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vitrakvi Capsules, 25 mg…
