FDA Approves ISOTRETINOIN — Aurobindo Pharma Limited
# FDA Approves Generic Isotretinoin ANDA from Aurobindo Pharma Aurobindo Pharma Limited received FDA approval for its generic isotretinoin oral formulation (ANDA218194) on January…
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# FDA Approves Generic Isotretinoin ANDA from Aurobindo Pharma Aurobindo Pharma Limited received FDA approval for its generic isotretinoin oral formulation (ANDA218194) on January…
# FDA Approves Generic Lacosamide from Aurobindo Pharma The U.S. Food and Drug Administration has approved Aurobindo Pharma Limited's generic lacosamide oral formulation, expandin…
# FDA Approves Zydus Lifesciences' Intravenous Methylene Blue Formulation Zydus Lifesciences Limited has received FDA approval for its intravenous methylene blue formulation (ANDA…
# FDA Approves SpringWorks Therapeutics' OGSIVEO for Dercum Disease Treatment SpringWorks Therapeutics, Inc. received FDA approval for OGSIVEO (nirogacestat), an oral gamma-secret…
Nuvaila Limited announced the 2023 FDA approval of WEZLANA, an intravenous ustekekinumab-auub, positioning the manufacturer to leverage significant market demand for chronic inflam…
# FDA Approves Novartis's Cosentyx (Secukinumab) Intravenous Formulation Novartis Pharmaceuticals Corporation received FDA approval for an intravenous formulation of Cosentyx (sec…
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…
# 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…
# 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…
# FDA Approves Steriscience Specialties' FOCINVEZ, Expanding IV Antiemetic Options in Competitive Market Steriscience Specialties Private Limited received FDA approval for FOCINVE…
(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…
# 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 …
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…
# 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 …