ALEMBIC PHARMA : USFDA TENTATIVE APPROVAL FOR LAROTRECTINIB CAPSULES 💊🇺🇸

• 🇺🇸 Received USFDA tentative approval for Larotrectinib Capsules 25 mg & 100 mg • 🎯 Drug is the generic version of Bayer's Vitrakvi, used for treatment of NTRK gene fusion-positive solid tumors • 🥇 Alembic is the sole first applicant with Paragraph IV certification for this product • ⏳ May be eligible for 180 days of generic marketing exclusivity in the US upon final approval • 💰 Product has an estimated US market size of $91 million for 12 months ending March 2026 (IQVIA) • 📋 Alembic now has 241 ANDA approvals from USFDA, including 221 final and 20 tentative approvals 🟢 Impact: Positive (Potential future exclusivity opportunity in a niche oncology product with a meaningful US market size.)

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