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Results For "FDA-approval"

438 News Found

Lupin receives USFDA approval for generic Ravicti oral liquid
Drug Approval | May 05, 2026

Lupin receives USFDA approval for generic Ravicti oral liquid

Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders


Cipla’s generic Ventolin HFA secures USFDA approval
Drug Approval | April 23, 2026

Cipla’s generic Ventolin HFA secures USFDA approval

Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market


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


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


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


Zydus receives USFDA approval for cevimeline hydrochloride capsules
Drug Approval | March 14, 2026

Zydus receives USFDA approval for cevimeline hydrochloride capsules

Cevimeline Hydrochloride Capsules 30mg are indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren’s syndrome.


Caplin Steriles gets FDA approval for desmopressin
Drug Approval | March 02, 2026

Caplin Steriles gets FDA approval for desmopressin

Desmopressin Acetate Injection is primarily used to treat central diabetes insipidus, haemophilia A, and von Willebrand disease


Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets
Drug Approval | February 26, 2026

Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets

The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder