Alembic Pharmaceuticals Receives USFDA Tentative Approval for Larotrectinib Capsules
Alembic Pharmaceuticals Limited has secured tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) covering Larotrectinib Capsules, available in 25 mg and 100 mg strengths. The approval pertains to the ANDA, which is therapeutically equivalent to Vitrakvi Capsules, 25 mg and 100 mg, a product manufactured by Bayer Healthcare Pharmaceuticals Inc.Larotrectinib is described as a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors. These specific patient groups must meet several criteria: they must have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, or be metastatic cases where surgical resection carries a risk of severe morbidity, or lack satisfactory alternative treatments and having progressed following prior treatment.
According to updates from the FDA’s online Paragraph IV database listings, Alembic stands as the sole first applicant who filed its ANDA for Larotrectinib Capsules (25 mg and 100 mg). This filing includes a Paragraph IV certification under the provisions of the Hatch-Waxman Act. If the USFDA grants final approval to this ANDA, the company could be eligible for up to 180 days of generic marketing exclusivity within the U.S.
The estimated market size for Larotrectinib Capsules, 25 mg and 100 mg, was reported at US$ 91 million for a twelve month period ending March 2026, based on data from IQVIA.
Alembic Pharmaceuticals Limited maintains significant approval history with the USFDA, recording a cumulative total of 241 ANDA approvals. These include 221 final approvals and 20 tentative approvals. The company, which has been operating since 1907 and is headquartered in India, is a vertically integrated research and development pharmaceutical manufacturer of generic products worldwide.
APLLTD Stock Price Movement
Shares of Alembic Pharmaceuticals Limited are edging higher to ₹741.5 as of 1:09 PM today, having gained 0.58% in live trading. The stock saw a traded volume of 29,987 shares during the current market session.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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