Lifestar
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 fo...
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Zydus
FDA Approves METHYLENE BLUE — Zydus Lifesciences Limited
# FDA Approves Zydus Lifesciences' Intravenous Methylene Blue Formulation Zydus Lifesciences Limited has received FDA approval for its intravenous me...
SpringWorks
FDA Approves OGSIVEO — SpringWorks Therapeutics, Inc.
# FDA Approves SpringWorks Therapeutics' OGSIVEO for Dercum Disease Treatment SpringWorks Therapeutics, Inc. received FDA approval for OGSIVEO (nirog...
Eli
FDA Approves ZEPBOUND — Eli Lilly and Company
Eli Lilly’s ZEPBOUND (tirzepatide) has received FDA approval to treat adults with diabetes mellitus type 2, significantly expanding the company’s domi...
Nuvaila
FDA Approves WEZLANA — Nuvaila Limited
Nuvaila Limited announced the 2023 FDA approval of WEZLANA, an intravenous ustekekinumab-auub, positioning the manufacturer to leverage significant ma...
Novartis
FDA Approves COSENTYX — Novartis Pharmaceuticals Corporation
# FDA Approves Novartis's Cosentyx (Secukinumab) Intravenous Formulation Novartis Pharmaceuticals Corporation received FDA approval for an intravenou...
MARKSANS
FDA Approves ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG — MARKSANS PHARMA LIMITED
On September 29, Marksans Pharma Limited received approval from the FDA for its ANDA217264 to market Esomeprazole Magnesium Delayed-Release Capsules, ...
Pfizer
FDA Approves BOSULIF — Pfizer Laboratories Div Pfizer Inc
Pfizer secured the FDA's approval of BOSULIF (bosutinib) on September 26, a regulatory win expected to bolster the pharmaceutical giant's oncology rev...
Gamida
FDA Approves APHEXDA — Gamida Cell Inc.
# FDA Approves Gamida Cell's APHEXDA for Hematopoietic Stem Cell Mobilization Gamida Cell Inc. received FDA approval for APHEXDA (motixafortide aceta...
Fresenius
FDA Approves GADOBUTROL — Fresenius Kabi USA, LLC
# FDA Approves Fresenius Kabi's Generic Gadobutrol, Expanding MRI Contrast Agent Competition Fresenius Kabi USA, LLC has received FDA approval for it...
Heritage
FDA Approves MYCOPHENOLATE MOFETIL — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
# FDA Approves Heritage Pharmaceuticals' Generic Mycophenolate Mofetil Heritage Pharmaceuticals Inc. (operating as Avet Pharmaceuticals Inc.) has rec...
Camber
FDA Approves LISDEXAMFETAMINE DIMESYLATE — Camber Pharmaceuticals, Inc.
# FDA Approves Generic Version of Lisdexamfetamine Dimesylate Camber Pharmaceuticals, Inc. received FDA approval for its generic formulation of lisde...
Alembic
FDA Approves BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited secured FDA approval for its generic Brimonidine Tartrate and Timolol Maleate ophthalmic solution, allowing the compan...
Steriscience
FDA Approves FOCINVEZ — Steriscience Specialties Private Limited
# FDA Approves Steriscience Specialties' FOCINVEZ, Expanding IV Antiemetic Options in Competitive Market Steriscience Specialties Private Limited rec...
SPECGX
FDA Approves Unknown Drug — SPECGX LLC
FDA has approved a generic drug from SPECGX LLC, representing an immediate entry for a branded product with significant commercial potential. The appr...
Janssen
FDA Approves TALVEY — Janssen Biotech, Inc.
(Janssen) announced Wednesday the FDA approval of Talvey (talquetamab), a novel antibody directed against both GPRC5D and BCMA, which targets multiple...
TORRENT
FDA Approves Unknown Drug — TORRENT
# FDA Approves Torrent Pharmaceutical's ANDA Application Torrent Pharmaceuticals received FDA approval for ANDA213405 on August 3, 2023, expanding it...
Daiichi
FDA Approves VANFLYTA — Daiichi Sankyo Inc.
# FDA Approves Daiichi Sankyo's VANFLYTA (quizartinib) for FLT3-Mutated Acute Myeloid Leukemia Daiichi Sankyo Inc. announced FDA approval of VANFLYTA...
Zydus
FDA Approves OXCARBAZEPINE — Zydus Lifesciences Limited
# FDA Approves Generic Oxcarbazepine Oral Formulation by Zydus Lifesciences Zydus Lifesciences Limited has received FDA approval for a generic versio...
Pfizer
FDA Approves NGENLA — Pfizer Laboratories Div Pfizer Inc
# FDA Approves Pfizer's NGENLA (somatrogon-ghla) for Growth Hormone Deficiency Pfizer has received FDA approval for NGENLA (somatrogon-ghla), a long-...