FDA Approves LENALIDOMIDE — Teva Pharmaceuticals, Inc.
# FDA Approves Generic Lenalidomide; Teva Pharmaceuticals Poised to Capture Market Share The FDA has approved Teva Pharmaceuticals' generic version of Lenalidomide (ANDA 201452), …
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# FDA Approves Generic Lenalidomide; Teva Pharmaceuticals Poised to Capture Market Share The FDA has approved Teva Pharmaceuticals' generic version of Lenalidomide (ANDA 201452), …
# Sun Pharmaceutical Receives FDA Approval for Generic Lenalidomide Sun Pharmaceutical Industries, Inc. has received FDA approval for its generic version of lenalidomide (ANDA2118…
# FDA Approves Generic Ramelteon by Micro Labs Limited The FDA has approved Micro Labs Limited's generic version of Ramelteon (ANDA215243), an oral melatonin receptor agonist used…
# FDA Approves Amneal Generic Drug Application Amneal Pharmaceuticals received FDA approval for ANDA213562 on January 31, 2023, expanding its generic drug portfolio and positionin…
Stemline Therapeutics, Inc. announced on January 27, 2023, that the FDA approved its oral selective estrogen receptor degrader (SERD) Elacestrant under the brand name ORSERDU, esta…
# FDA Approves Gland Pharma's Generic Ketamine Hydrochloride Injection Gland Pharma Limited received FDA approval for its generic ketamine hydrochloride intramuscular injection, e…
ZYDUS PHARMS secured an FDA approval for its generic application ANDA209655, positioning the company to capture future market share and increase therapeutic accessibility following…
TheracosBio, LLC received FDA approval for the oral diabetes agent BRENZAVVY, a milestone that establishes its presence in the competitive SGLT2 inhibitor market and is likely to c…
Meitheal Pharmaceuticals Inc. has secured FDA approval for NELARABINE (ANDA216038), signaling the company's entry into the oncology market and initiating a comprehensive strategic …
ONESOURCE SPECIALTY PHARMA LIMITED announced the approval of intravenous mycophenolate mofetil under ANDA 216390, which could strengthen the biologic immunosuppressant market by ex…
# FDA Approves Gilead Sciences' SUNLENCA (lenacapavir sodium), a First-in-Class HIV Treatment Gilead Sciences, Inc. received FDA approval for SUNLENCA (lenacapavir sodium), positi…
# FDA Approves Gilead Sciences' SUNLENCA (Lenacapavir Sodium) for HIV Treatment Gilead Sciences, Inc. received FDA approval for SUNLENCA (lenacapavir sodium), an oral HIV capsid i…
# FDA Approves Generic Brimonidine Tartrate from Apotex Corp. The FDA has approved Apotex Corp.'s abbreviated new drug application for generic brimonidine tartrate ophthalmic solu…
# FDA Approves NorthStar RxLLC's Generic Levothyroxine Sodium The U.S. Food and Drug Administration has approved NorthStar RxLLC's abbreviated new drug application for levothyroxi…
Mirati Therapeutics, Inc. received FDA approval for its oral KRAS G12C inhibitor KRAZATI (adagrasib), a move that solidifies its position in a highly competitive oncology landscape…
Cycle Pharmaceuticals Ltd announced the FDA approval of TASCENSO ODT (fingolimod lauryl sulfate), its new once-daily oral formulation for demyelinating diseases, a move that increa…
Ingenus Pharmaceuticals, LLC announced FDA approval of its ANDA for oral carbamazepine tablets, fulfilling the need for a generic alternative to the widely used anticonvulsant bran…
On November 30, 2022, **Epic Pharma, LLC** announced the approval of its Abbreviated New Drug Application (ANDA) 215332 for OXCARBAZEPINE, ensuring continued market access for the …
Aurobindo Pharma Limited secured FDA approval for its generic Carbidopa and Levodopa oral tablet, positioning the company to capitalize on cost-sensitive demand in the Parkinson’s …
The FDA granted accelerated approval to Provention Bio’s TEPLIZUMAB-MZWV (TZIELD), a novel immunotherapy for type 1 diabetes, significantly bolstering the company’s product pipelin…