30-Oct-2026 18:29:29
APLLTDGeneral news
ALEMBIC PHARMA : RECEIVES USFDA FINAL APPROVAL FOR VENETOCLAX TABLETS
• USFDA final approval for ANDA for Venetoclax Tablets, 10 mg, 50 mg and 100 mg • Product is therapeutically equivalent to Venclexta Tablets of AbbVie Inc. • Alembic was first ANDA applicant with paragraph IV certification; may be eligible for 180 days of generic drug exclusivity • Indicated for adult CLL/SLL patients and, in combination, for newly diagnosed AML in adults 75 years or older or with comorbidities • IQVIA estimates US market size of US $1,584 million for 12 months ending June 2026 • Cumulative 248 ANDA approvals (228 final and 20 tentative) from USFDA
Alembic Pharmaceuticals Limited
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