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Results For "generic"

845 News Found

Orbicular, Apotex win tentative USFDA nod for generic Ozempic
Drug Approval | April 11, 2026

Orbicular, Apotex win tentative USFDA nod for generic Ozempic

Hyderabad-based peptide specialist strengthens complex generics credentials as Apotex prepares for U.S. commercialization of semaglutide injection


Glenmark gets USFDA approval for generic Endometrin vaginal inserts
Drug Approval | April 09, 2026

Glenmark gets USFDA approval for generic Endometrin vaginal inserts

Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million


India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters
Drug Approval | April 09, 2026

India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters

In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga


Lupin wins USFDA nod for generic Dapagliflozin tablets
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


Aurobindo Pharma wins USFDA approval for generic Xigduo XR
Drug Approval | April 08, 2026

Aurobindo Pharma wins USFDA approval for generic Xigduo XR

Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually


Zydus gets USFDA final approval for generic Dapagliflozin with 180-day shared exclusivity
Drug Approval | April 08, 2026

Zydus gets USFDA final approval for generic Dapagliflozin with 180-day shared exclusivity

Immediate opportunity in the $10.2 billion U.S. market as the diabetes therapy will be manufactured at Zydus’ SEZ Ahmedabad facility


Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity
Drug Approval | April 07, 2026

Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity

Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.


Cipla strengthens US respiratory portfolio with final FDA nod for generic Nintedanib
Drug Approval | April 04, 2026

Cipla strengthens US respiratory portfolio with final FDA nod for generic Nintedanib

ANDA approval for 100 mg and 150 mg capsules targeting idiopathic pulmonary fibrosis opens access to a $3.76 billion market in USA


Glenmark Pharmaceuticals USA launches authorized generic of Savella tablets
News | March 20, 2026

Glenmark Pharmaceuticals USA launches authorized generic of Savella tablets

Glenmark's Milnacipran Hydrochloride Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg is the authorized generic to Savella Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg