Drug Approval | April 08, 2026
Lupin wins USFDA nod for generic Dapagliflozin tablets
Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market
Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market
Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size
Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually
This marks a meaningful step in the company's continued expansion in the region
Beyond clinical trials, real-world evidence is adding weight to AbbVie’s claims
TERN-701, a next-generation therapy targeting chronic myeloid leukemia (CML), a form of blood cancer that still presents treatment challenges despite decades of advances
The newly classified assays join Roche’s Ionify 25-Hydroxy Vitamin D total assay in a growing U.S. portfolio
Marks significant milestone for breakthrough biologic to treat rare blood cancers
The approval comes after a systematic review of published literature
The company says those insights can power advanced analytics and real-world evidence (RWE), helping researchers improve trial design, study feasibility, and recruitment strategies
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