FDA Approves LOPRESSOR — VALIDUS PHARMACEUTICALS LLC
On August 28, 2025, Validus Pharmaceuticals received FDA approval for Lopressor (metoprolol tartrate), which the company characterized as a substantial strategic move to scale oral…
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On August 28, 2025, Validus Pharmaceuticals received FDA approval for Lopressor (metoprolol tartrate), which the company characterized as a substantial strategic move to scale oral…
First Nation Group, LLC secured FDA approval for its generic version of DIVALPROEX SODIUM on August 12, 2025, targeting the oral formulation previously marketed under another brand…
# FDA Approves Boehringer Ingelheim's HERNEXEOS (Zongertinib) for Oral Administration Boehringer Ingelheim Pharmaceuticals has received FDA approval for HERNEXEOS (zongertinib), a…
The FDA on August 8, 2025, approved Voriconazole Oral Suspension (ANDA211598) from Camber Pharmaceuticals, Inc., positioning the company to capture significant market share in the …
Following the FDA’s August 7 approval of generic Gabapentin, Stallion Laboratories Private Limited adds a new player to a crowded and highly competitive market, potentially intensi…
# FDA Approves Spironolactone Generic from Camber Pharmaceuticals Camber Pharmaceuticals, Inc. received FDA approval for its generic spironolactone oral formulation, expanding the…
Alembic Pharmaceuticals Inc. secured FDA approval on July 25, 2025, for its generic Carbamazepine oral tablet, enabling the company to expand its market presence within the establi…
LEO Pharma, Inc. received FDA approval for the topical delgocitinib formulation under the brand name ANZUPGO, marking a strategic expansion of its portfolio for severe inflammatory…
DR REDDYS LABS SA has secured FDA approval for its Abbreviated New Drug Application (ANDA215276), signaling a pivotal expansion of its generic portfolio and expected to drive incre…
Alembic Pharmaceuticals Limited announced on Friday, June 27, 2025, the approval of an ANDA by the U.S. FDA for doxorubicin hydrochloride injection, a generic version of the oncolo…
# FDA Approves ANDA Application for TP ANDA Holdings TP ANDA Holdings received FDA approval for ANDA219509 on June 23, 2025, potentially strengthening its position in the generic …
Dr. Reddys Laboratories Inc. has secured FDA approval for its ANDA82176 generic version of Qsymia (phentermine and topiramate extended-release), entering a significant weight-manag…
NUVATION BIO announced Tuesday that the FDA has accepted its new drug application for its lead immune-oncology asset, a critical step that catalyzes the upcoming Phase 3 review and…
Fresenius Kabi USA, LLC announced on June 9 a new FDA approval for rocuronium bromide, potentially revitalizing the generic neuromuscular blockers market by strengthening competiti…
Azurity Pharmaceuticals secured FDA approval Friday for WIDAPLIK (telmisartan, amlodipine and indapamide), a new oral antihypertensive. This launch strengthens Azurity’s portfolio …
Devatis Inc. secured FDA approval for its oral Lenalidomide generic, positioning the manufacturer to capture potential market share in the myeloma treatment space amidst anticipate…
On April 17, 2025, Bristol received approval for a new drug application (NDA 220073), a development that is poised to reshape the competitive landscape for the specified therapeuti…
# FDA Approves Generic Imatinib Mesylate Camber Pharmaceuticals, Inc. has received FDA approval for its generic formulation of imatinib mesylate, an oral tyrosine kinase inhibitor…
BIONPHARMA INC. announced the U.S. approval of generic metformin hydrochloride oral solution (ANDA 219151), a move that is expected to bolster supply chain stability for the widely…
Fresenius Kabi USA announced on March 14, 2025, the FDA approval of its biosimilar TOCILIZUMAB (TYENNE), a fully human monoclonal antibody for injection. This approval introduces a…