Latest news and insights on the pharmaceutical industry | Indian Pharma Post

Results For "USFDA"

1405 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 gets USFDA approval for Dapagliflozin with 180-day exclusivity
Drug Approval | April 08, 2026

Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity

Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size


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.


Marksans Pharma receives USFDA approval for Benzonatate capsules
Drug Approval | April 02, 2026

Marksans Pharma receives USFDA approval for Benzonatate capsules

Benzonatate is a non-narcotic antitussive that numbs stretch receptors in the respiratory tract


Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets
Drug Approval | March 28, 2026

Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets

Paroxetine extended-release tablets are indicated for the treatment of major depressive disorder