Alembic Pharma Receives USFDA Tentative Approval for Larotrectinib Capsules

Alembic Pharmaceuticals received USFDA tentative approval for Larotrectinib Capsules, targeting a market estimated at US$ 91 million. As the sole first applicant with a Paragraph IV certification, the company may be eligible for 180 days of US generic marketing exclusivity upon final approval.