Alembic Pharmaceuticals Limited announces USFDA Tentative Approval for Binimetinib Tablets, 45 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) Binimetinib Tablets, 45 mg. Alembic had previously received tentative approval for Binimetinib Tablets, 15mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Mektovi Tablets, 15 mg of Array. Binimetinib is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. It is also indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. Refer label for a detailed indication.

Based on FDA's Paragraph IV Certifications List, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45mg, 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 US.

Binimetinib Tablets have an estimated market size of US$ 259 million for twelve months ending March 2026 according to IQVIA.

Alembic has a cumulative total of 242 ANDA approvals (222 final approvals and 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 749.75 as compared to the previous close of Rs. 745.60. The total number of shares traded during the day was 1210 in over 97 trades.

The stock hit an intraday high of Rs. 750.95 and intraday low of 743.15. The net turnover during the day was Rs. 903736.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA TentativeApproval ANDA BinimetinibTablets