FDA Approves LACOSAMIDE — Amneal Pharmaceuticals of New York LLC
On March 17, 2022, Amneal Pharmaceuticals of New York LLC received FDA approval for its Abbreviated New Drug Application (ANDA) #204857 for the generic version of the drug lacosami…
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On March 17, 2022, Amneal Pharmaceuticals of New York LLC received FDA approval for its Abbreviated New Drug Application (ANDA) #204857 for the generic version of the drug lacosami…
Mylan Pharmaceuticals Inc. has secured FDA approval for its ANDA206497, granting market access to the transdermal form of methylphenidate, a critical development that expands compe…
# FDA Approves Pregabalin Generic from Eskayef Pharmaceuticals Eskayef Pharmaceuticals Limited received FDA approval for its generic pregabalin oral formulation (ANDA212988), addi…
Sobi, Inc. received FDA approval for VONJO (pacritinib) to treat adult patients with Philadelphia-negative myelofibrosis who have intolerant or refractory to ruxolitinib, a develop…
# FDA Approves Generic Divalproex Sodium for BluePoint Laboratories BluePoint Laboratories has received FDA approval for its generic divalproex sodium oral formulation, expanding …
ScieGen Pharmaceuticals, Inc. secured approval for generic Metformin HCl Extended-Release Tablets, addressing a significant portion of the massive Type 2 diabetes market with the f…
INGENUS PHARMS is expected to see a positive impact on its consolidated sales following the receipt of FDA approval for its generic equivalent under ANDA215584, which strengthens i…
# FDA Approves Apotex's Generic Brimonidine Tartrate Ophthalmic Treatment Apotex Corp. received FDA approval for its generic brimonidine tartrate ophthalmic formulation, expanding…
# FDA Approves Genentech's VABYSMO for Retinal Disease Treatment Genentech has received FDA approval for VABYSMO (faricimab), a novel intravitreal injection marking the company's …
Sandoz Inc. received FDA approval to market the generic version of tafluprost (ANDA 209040) on Jan. 28, 2022, introducing a new low-cost option to the ocular hypertension and open-…
# FDA Approval Newswire Mylan received FDA approval for a generic drug application (ANDA210275) on January 26, 2022, positioning the company to capture additional market share in …
Hikma Pharmaceuticals USA Inc. received FDA approval for a new generic of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate, raising potential concerns about medication sh…
On January 25, 2022, Teva Pharmaceuticals received FDA approval for ANDA211272, a move which, while filling a specific regulatory void, does not currently generate significant mark…
# FDA Approves Generic Vigabatrin The FDA has approved Zydus Pharmaceuticals' generic version of vigabatrin, an oral antiepileptic medication, potentially expanding market competi…
New York, January 14, 2022 – U.S. Pharmaceuticals announced today the FDA approval of CIBINQO (abrocitinib), a novel oral therapy for chronic urticaria, marking a significant comme…
# FDA Approves Alembic Pharmaceuticals' Doxycycline Hyclate Generic Alembic Pharmaceuticals Limited has received FDA approval for its generic doxycycline hyclate oral formulation,…
Cranbury Pharmaceuticals, LLC won FDA approval for its ANDA201295 generic of Hydrocodone Bitartrate and Acetaminophen, marking the company's entry into a competitive market that ma…
# FDA Approves Novartis's LEQVIO (Inclisiran) for Cholesterol Management The FDA has approved Novartis Pharmaceuticals Corporation's LEQVIO (inclisiran sodium), a groundbreaking s…
# FDA Approves New Generic Drug Application for PharmObedient The FDA has approved ANDA 208120 for PharmObedient, expanding the manufacturer's generic drug portfolio and positioni…
# FDA Approves New Oral Formulation of Janssen's XARELTO (Rivaroxaban) The U.S. Food and Drug Administration has approved Janssen Pharmaceuticals' XARELTO (rivaroxaban) oral formu…