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# FDA Approves Generic Version of Lisdexamfetamine Dimesylate Camber Pharmaceuticals, Inc. received FDA approval for its generic formulation of lisdexamfetamine dimesylate on Augu…
Alembic Pharmaceuticals Limited secured FDA approval for its generic Brimonidine Tartrate and Timolol Maleate ophthalmic solution, allowing the company to expand its product portfo…
Camber Pharmaceuticals, Inc. announced the approval of its Abbreviated New Drug Application for lisdexamphetamine dimesylate, a strategic development that enters the generic market…
Solco Healthcare US, LLC has received FDA approval for the oral lisdexamphetamine dimesylate capsules (ANDA 216266), paving the way for the anticipated entry of a key generic versi…
# FDA Approves Steriscience Specialties' FOCINVEZ, Expanding IV Antiemetic Options in Competitive Market Steriscience Specialties Private Limited received FDA approval for FOCINVE…
FDA has approved a generic drug from SPECGX LLC, representing an immediate entry for a branded product with significant commercial potential. The approval targets a substantial mar…
Ipsen Biopharmaceuticals, Inc. announced FDA approval of palovarotene soft capsules (Sohonos), intended for pediatric patients with amenable ichthyoses, which establishes a novel t…
(Janssen) announced Wednesday the FDA approval of Talvey (talquetamab), a novel antibody directed against both GPRC5D and BCMA, which targets multiple myeloma patients with ineligi…
# FDA Approves Torrent Pharmaceutical's ANDA Application Torrent Pharmaceuticals received FDA approval for ANDA213405 on August 3, 2023, expanding its generic drug portfolio and p…
Mylan Pharmaceuticals Inc. announced on Friday the U.S. approval of its ANDA for saxagliptin and metformin, initiating a new competitive entry into the expanding diabetes market se…
WG Critical Care, LLC announced the FDA approval of its Meropenem IV injection (NDA215212) on July 26, 2023, positioning the manufacturer to strengthen its portfolio against existi…
# FDA Approves Daiichi Sankyo's VANFLYTA (quizartinib) for FLT3-Mutated Acute Myeloid Leukemia Daiichi Sankyo Inc. announced FDA approval of VANFLYTA (quizartinib dihydrochloride)…
# FDA Approves Generic Oxcarbazepine Oral Formulation by Zydus Lifesciences Zydus Lifesciences Limited has received FDA approval for a generic version of oxcarbazepine, an anticon…
# FDA Approves Pfizer's NGENLA (somatrogon-ghla) for Growth Hormone Deficiency Pfizer has received FDA approval for NGENLA (somatrogon-ghla), a long-acting growth hormone therapy …
Pfizer has announced the FDA approval of the oral drug Ritlecitinib Tosylate (LITFULO) for the treatment of alopecia areata, marking the pharma giant's latest expansion into the co…
Genentech, Inc. received FDA approval in June 2023 for its intravenous antibody drug Glufitamab under the brand name COLUMVI, a significant milestone for the company’s portfolio of…
Camber Pharmaceuticals has received FDA approval for its Eplerenone oral tablets, serving as a new generic entry in the market for this heart failure treatment. The approval provid…
BPI LABS has secured a key regulatory milestone with today’s FDA approval of ANDA 214283, signaling the company’s intent to enter a substantial and accessible therapeutic market. T…
# FDA Approves Pfizer's Paxlovid as Antiviral Treatment Pfizer announced FDA approval of Paxlovid (nirmatrelvir and ritonavir) on May 25, 2023, solidifying the company's position …
# FDA Approves NorthStar RxLLC's Haloperidol Decanoate for Intramuscular Administration The FDA has approved NorthStar RxLLC's haloperidol decanoate intramuscular injection (ANDA2…