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

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

Stereotaxis bags FDA clearance for next-gen cath lab tech

ImmunityBio responds to FDA concerns over promotional content

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

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

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

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

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

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