FDA Approves TERLIVAZ — Mallinckrodt Hospital Products Inc.
Mallinckrodt Hospital Products Inc. announced FDA approval of the intravenous drug TERLIPRESSIN (Generic: TERLIPRESSIN), a significant milestone for the company’s hospital portfoli…
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Mallinckrodt Hospital Products Inc. announced FDA approval of the intravenous drug TERLIPRESSIN (Generic: TERLIPRESSIN), a significant milestone for the company’s hospital portfoli…
Zydus Pharmaceuticals USA Inc. announced on Tuesday the FDA approval of a generic version of global immunomodulatory drug manufacturer Johnson & Johnson's oral drug Lenalidomide, a…
The FDA has granted approval to Squibb’s oral drug SOTYKTU (deucravacitinib) for the treatment of moderate-to-severe plaque psoriasis, a development that may allow the pharmaceutic…
Novadoz Pharmaceuticals LLC has secured FDA approval for its generic Vigabatrin oral formulation, positioning the company to capitalize on cost-savings trends by entering the marke…
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# FDA Approves Generic Lenalidomide from Alvogen Alvogen, Inc. has received FDA approval for generic lenalidomide, an oral immunomodulatory drug used to treat multiple myeloma and…
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Apotex Corp. received the FDA approval for its generic Lenalidomide on Aug. 30, expanding its portfolio to challenge competitors within the myeloma treatment market. The clearance …
Hikma Pharmaceuticals USA Inc. received FDA approval for its generic oral version of Vigabatrin in August, a move expected to bolster the company's anticonvulsant portfolio and dri…
Northstar Rx LLC has received FDA approval for IV pantoprazole sodium (ANDA 215860), a significant move that promises to bolster the availability of a first-line injectable treatme…
# FDA Approves Axsome Therapeutics' AUVELITY for Major Depressive Disorder Axsome Therapeutics received FDA approval for AUVELITY (dextromethorphan hydrobromide/bupropion hydrochl…
Advagen Pharma Limited received FDA approval on August 18, 2022, for the Abbreviated New Drug Application ANDA215724, finalizing its launch of the oral acyclovir generic. This acti…
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AbbVie announced the FDA approval of risankizumab-RZAA (Skyrizi) for intravenous use, a formulation that may broaden the biologic’s market presence alongside its current subcutaneo…
Camber Pharmaceuticals, Inc. announced late Monday the approval of its Abbreviated New Drug Application, No. ANDA215776, for the oral formulation of Naproxen, triggering a green li…
# FDA Approves Eugia US LLC's Generic Leuprolide Acetate Eugia US LLC received FDA approval for its generic leuprolide acetate formulation, marking another entry into the competit…
# FDA Approves Aurobindo Pharma's Generic Vigabatrin, Expanding Treatment Options for Seizure Disorders The FDA has approved Aurobindo Pharma Limited's generic formulation of viga…
# FDA Approves Generic Version of Pomalidomide; Teva Gains Market Entry Teva Pharmaceuticals, Inc. received FDA approval for its generic oral pomalidomide formulation (ANDA209956)…
# FDA Approves Lupin Ltd's Generic Drug Application Lupin Ltd has received FDA approval for generic drug application ANDA091040, expanding the company's portfolio in the competiti…