Regulatory | 14 June 2026
Alembic secures USFDA nod for Tretinoin Cream strengthening generics portfolio
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
Approval is based on results from the phase 3 OASIS 4 clinical trial
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
Approval expands treatment options for patients with unresectable or metastatic HER2-positive breast cancer
Broadening access for children & patients with inhibitor-complicated hemophilia
Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations
Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval
The approval is expected to support the company’s presence in regulated international markets and further strengthen its position as a reliable pharma manufacturing partner
The filing is backed by Phase III data from the lidERA Breast Cancer study
Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials is the bioequivalent to the reference listed drug (RLD) Halaven injection of Eisai, Inc.
First immunotherapy combination approved in the US for BCG-naïve high-risk NMIBC demonstrates a 32% reduction in the risk of disease recurrence, progression, or death
The approval is supported by results from the Phase 3 SWOG 1826 trial
The therapy also delivered significant improvements in key liver enzyme markers
The approval marks a major milestone in the global fight against antimicrobial resistance
The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026
The decision clears the drug as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer
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