FDA Approves ATROPINE SULFATE — Lifestar Pharma LLC
The FDA has granted approval to Lifestar Pharma LLC’s ANDA for Atropine Sulfate Ophthalmic Solution, a generic alternative to branded versions used for myopia control. The approval…
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The FDA has granted approval to Lifestar Pharma LLC’s ANDA for Atropine Sulfate Ophthalmic Solution, a generic alternative to branded versions used for myopia control. The approval…
AUROBINDO PHARMA LTD announced a new drug approval today, marking a strategic expansion of its generic portfolio as the company seeks to leverage this regulatory clearance to drive…
# FDA Approves Zydus Lifesciences' Intravenous Methylene Blue Formulation Zydus Lifesciences Limited has received FDA approval for its intravenous methylene blue formulation (ANDA…
The FDA has approved Novartis’ NDA218276 for FABHALTA (iptacopan hydrochloride), an oral drug ultimately aiming to disrupt the complement cascade. This approval positions Novartis …
Biocon Pharma Inc. announced the U.S. FDA approval of its Mycophenolic Acid tablets, impacting the competitive landscape by expanding generic options for immunosuppressant therapy.…
# FDA Approves SpringWorks Therapeutics' OGSIVEO for Dercum Disease Treatment SpringWorks Therapeutics, Inc. received FDA approval for OGSIVEO (nirogacestat), an oral gamma-secret…
AstraZeneca announced Friday the FDA granted approval for [Insert Substance Name and Description Here], marking a regulatory milestone that should bolster the company’s market posi…
Eli Lilly’s ZEPBOUND (tirzepatide) has received FDA approval to treat adults with diabetes mellitus type 2, significantly expanding the company’s dominance in the rapidly growing o…
Zydus Lifesciences Limited received FDA approval for its combination tablet of sitagliptin and metformin hydrochloride, a move aimed at broadening accessibility for type 2 diabetes…
Nuvaila Limited announced the 2023 FDA approval of WEZLANA, an intravenous ustekekinumab-auub, positioning the manufacturer to leverage significant market demand for chronic inflam…
NorthStar RxLLC announced on October 20, 2023, that the FDA has granted approval for its Oxcarbazepine tablet, ANDA 216749, offering a potential high-demand generic alternative to …
UCB, Inc. announced on Thursday that the FDA granted accelerated approval to its novel antiphospholipid syndrome drug ZILBRYSQ (zilucoplan), signaling a strategic entry into the un…
# FDA Approves Novartis's Cosentyx (Secukinumab) Intravenous Formulation Novartis Pharmaceuticals Corporation received FDA approval for an intravenous formulation of Cosentyx (sec…
Laurus Labs Limited received FDA approval on October 5, 2023, for its generic product under application number ANDA217631, signaling a significant expansion of supply for the oral …
On September 29, Marksans Pharma Limited received approval from the FDA for its ANDA217264 to market Esomeprazole Magnesium Delayed-Release Capsules, 20 mg. This clearance is expec…
Pfizer secured the FDA's approval of BOSULIF (bosutinib) on September 26, a regulatory win expected to bolster the pharmaceutical giant's oncology revenue streams and expand its ma…
GlaxoSmithKline plc has secured regulatory approval from the FDA for Momelotinib Dihydrochloride Monohydrate (NDA216873), a novel oral therapy aiming to fill the critical need for …
# FDA Approves Gamida Cell's APHEXDA for Hematopoietic Stem Cell Mobilization Gamida Cell Inc. received FDA approval for APHEXDA (motixafortide acetate), a subcutaneous injection …
# FDA Approves Fresenius Kabi's Generic Gadobutrol, Expanding MRI Contrast Agent Competition Fresenius Kabi USA, LLC has received FDA approval for its generic gadobutrol formulati…
# FDA Approves Heritage Pharmaceuticals' Generic Mycophenolate Mofetil Heritage Pharmaceuticals Inc. (operating as Avet Pharmaceuticals Inc.) has received FDA approval for its gen…