Alembic Pharmaceuticals Ltd announces USFDA Tentative Approval for Larotrectinib Capsules, 25 mg and 100 mg

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 and 100 mg, of Bayer Healthcare Pharmaceuticals Inc. (Bayer). Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: a) have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, b) are metastatic or where surgical resection is likely to result in severe morbidity, and c) have no satisfactory alternative treatments or that have progressed following treatment. Refer label for a detailed indication.

Based on the most recent update to the FDA's online Paragraph IV database listings, Alembic is the sole first applicant to have filed its ANDA for Larotrectinib Capsules (25 mg and 100 mg), containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Upon final approval of this ANDA by the USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the U.S.

Larotrectinib Capsules, 25 mg and 100 mg, have an estimated market size of US$ 91 million for twelve months ending March 2026 according to IQVIA.

Alembic has a cumulative total of 241 ANDA approvals (221 final approvals and 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 735.00 as compared to the previous close of Rs. 736.50. The total number of shares traded during the day was 12543 in over 609 trades.

The stock hit an intraday high of Rs. 759.70 and intraday low of 731.65. The net turnover during the day was Rs. 9340970.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA TentativeApproval LarotrectinibCapsules