PAI
FDA Approves VORICONAZOLE — PAI Holdings, LLC dba PAI Pharma
# FDA Approves PAI Pharma's Generic Voriconazole Injection PAI Holdings, LLC dba PAI Pharma received FDA approval for its generic voriconazole intrav...
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Zydus
FDA Approves LEUPROLIDE ACETATE — Zydus Pharmaceuticals USA Inc.
# FDA Approves Generic Leuprolide Acetate from Zydus Pharmaceuticals Zydus Pharmaceuticals USA Inc. received FDA approval for generic leuprolide acet...
Amneal
FDA Approves IOHEXOL — Amneal Pharmaceuticals Private Limited
Amneal Pharmaceuticals Private Limited secured FDA approval for its intra-articular formulation of IOHEXOL, positioning the drugmaker to capture marke...
Merck
FDA Approves KEYTRUDA QLEX — Merck Sharp & Dohme LLC
Merck is slated to launch KEYTRUDA QLEX, a novel subcutaneous formulation of pembrolizumab, on September 19, 2025, anticipating a shift in market dyna...
LUPIN
FDA Approves Unknown Drug — LUPIN
# FDA Approves Lupin's Generic Drug Application Lupin Limited received FDA approval for its abbreviated new drug application (ANDA 214398) on Septemb...
OWP
FDA Approves SUBVENITE — OWP Pharmaceuticals, Inc.
OWP Pharmaceuticals, Inc. received FDA approval on September 16, 2025, for its generic version of the antiepileptic drug LAMOTRIGINE targeting epileps...
AstraZeneca
FDA Approves KOSELUGO — AstraZeneca Pharmaceuticals LP
# FDA Approves AstraZeneca's KOSELUGO (selumetinib) for Neurofibromatosis Type 1 AstraZeneca Pharmaceuticals LP has received FDA approval for KOSELUG...
Eisai
FDA Approves LECANEMAB AUTOINJECTOR — Eisai Inc.
Eisai Inc. announced Friday the FDA approval of the subcutaneous lecanemab (Leqembi) formulation, expanding the treatment accessibility for early Alzh...
Boehringer
FDA Approves HERNEXEOS — Boehringer Ingelheim Pharmaceuticals, Inc.
# FDA Approves Boehringer Ingelheim's HERNEXEOS (Zongertinib) for Oral Administration Boehringer Ingelheim Pharmaceuticals has received FDA approval ...
Camber
FDA Approves SPIRONOLACTONE — Camber Pharmaceuticals, Inc.
# FDA Approves Spironolactone Generic from Camber Pharmaceuticals Camber Pharmaceuticals, Inc. received FDA approval for its generic spironolactone o...
Alembic
FDA Approves CARBAMAZEPINE — Alembic Pharmaceuticals Inc.
Alembic Pharmaceuticals Inc. secured FDA approval on July 25, 2025, for its generic Carbamazepine oral tablet, enabling the company to expand its mark...
LEO
FDA Approves ANZUPGO — LEO Pharma, Inc
LEO Pharma, Inc. received FDA approval for the topical delgocitinib formulation under the brand name ANZUPGO, marking a strategic expansion of its por...
DR
FDA Approves Unknown Drug — DR REDDYS LABS SA
DR REDDYS LABS SA has secured FDA approval for its Abbreviated New Drug Application (ANDA215276), signaling a pivotal expansion of its generic portfol...
TP
FDA Approves Unknown Drug — TP ANDA HOLDINGS
# FDA Approves ANDA Application for TP ANDA Holdings TP ANDA Holdings received FDA approval for ANDA219509 on June 23, 2025, potentially strengthenin...
Dr.Reddys
FDA Approves PHENTERMINE AND TOPIRAMATE EXTENDED-RELEASE — Dr.Reddys Laboratories Inc
Dr. Reddys Laboratories Inc. has secured FDA approval for its ANDA82176 generic version of Qsymia (phentermine and topiramate extended-release), enter...
Fresenius
FDA Approves ROCURONIUM — Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC announced on June 9 a new FDA approval for rocuronium bromide, potentially revitalizing the generic neuromuscular blockers mar...
Azurity
FDA Approves WIDAPLIK — Azurity Pharmaceuticals, Inc.
Azurity Pharmaceuticals secured FDA approval Friday for WIDAPLIK (telmisartan, amlodipine and indapamide), a new oral antihypertensive. This launch st...
Devatis
FDA Approves LENALIDOMIDE — Devatis Inc.
Devatis Inc. secured FDA approval for its oral Lenalidomide generic, positioning the manufacturer to capture potential market share in the myeloma tre...
BRISTOL
FDA Approves Unknown Drug — BRISTOL
On April 17, 2025, Bristol received approval for a new drug application (NDA 220073), a development that is poised to reshape the competitive landscap...
Camber
FDA Approves IMATINIB MESYLATE — Camber Pharmaceuticals, Inc.
# FDA Approves Generic Imatinib Mesylate Camber Pharmaceuticals, Inc. has received FDA approval for its generic formulation of imatinib mesylate, an ...