FDA Approves Unknown Drug — CIPLA
# FDA Approves CIPLA's Generic Drug Application Cipla Limited received FDA approval for its abbreviated new drug application (ANDA 213165) on February 2, 2026, positioning the com…
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# FDA Approves CIPLA's Generic Drug Application Cipla Limited received FDA approval for its abbreviated new drug application (ANDA 213165) on February 2, 2026, positioning the com…
# FDA Approves Somerset Therapeutics' Generic Rilpivirine Somerset Therapeutics, LLC has received FDA approval for its generic rilpivirine hydrochloride oral formulation (ANDA2187…
# FDA Approves Generic Difluprednate Ophthalmic from Alembic Pharmaceuticals The FDA has approved Alembic Pharmaceuticals' generic difluprednate ophthalmic formulation, expanding …
Novitium Pharma secured FDA approval for its ANDA 219119, a milestone anticipated to accelerate revenue generation and strengthen the company's competitive market position.
# FDA Approves Novo Nordisk's Oral Semaglutide (Wegovy) Novo Nordisk Pharmaceutical Industries, LP received FDA approval for the oral formulation of semaglutide (Wegovy) on Decemb…
Following the FDA approval of Camber Pharmaceuticals' and the BioSignia Partners-managed consortium's ANDA for Meloxifene tablets on December 18, the company is poised to strengthe…
LIB Therapeutics, Inc. has received FDA approval for LEROCHOL (lerodalcibep), a novel injection scheduled to launch on December 12, 2025, marking the company's entry into a rapidly…
On December 10, 2025, SpecGx LLC received FDA approval for the generic sublingual tablet formulation of Buprenorphine Hydrochloride (ANDA 218473), a significant development that is…
# FDA Approves Generic MACITENTAN from Novugen Pharma The FDA has approved Novugen Pharma's generic version of MACITENTAN, an endothelin receptor antagonist used to treat pulmonar…
# FDA Approves Generic Lenalidomide from Accord Healthcare Inc. Accord Healthcare Inc. received FDA approval for generic lenalidomide (ANDA218872), marking another significant ent…
# FDA Approves PAI Pharma's Generic Voriconazole Injection PAI Holdings, LLC dba PAI Pharma received FDA approval for its generic voriconazole intravenous injection (ANDA220043), …
# FDA Approves Generic Leuprolide Acetate from Zydus Pharmaceuticals Zydus Pharmaceuticals USA Inc. received FDA approval for generic leuprolide acetate (ANDA215826), marking anot…
Amneal Pharmaceuticals Private Limited secured FDA approval for its intra-articular formulation of IOHEXOL, positioning the drugmaker to capture market share in the orthopedic nich…
Boehringer Ingelheim Pharmaceuticals, Inc. has received FDA approval for the oral prescription drug NERANDOMILAST (NDA218764), branded as JASCAYD. This milestone could significantl…
Northeast Ohio-based CELLTRION INC. announced today that the U.S. FDA granted approval for a substantial new entity, triggering a significant market opportunity for the biotechnolo…
Merck is slated to launch KEYTRUDA QLEX, a novel subcutaneous formulation of pembrolizumab, on September 19, 2025, anticipating a shift in market dynamics by potentially reducing i…
# FDA Approves Lupin's Generic Drug Application Lupin Limited received FDA approval for its abbreviated new drug application (ANDA 214398) on September 16, 2025, expanding the com…
OWP Pharmaceuticals, Inc. received FDA approval on September 16, 2025, for its generic version of the antiepileptic drug LAMOTRIGINE targeting epilepsy and bipolar disorder; the ap…
# FDA Approves AstraZeneca's KOSELUGO (selumetinib) for Neurofibromatosis Type 1 AstraZeneca Pharmaceuticals LP has received FDA approval for KOSELUGO (selumetinib), an oral MEK i…
Eisai Inc. announced Friday the FDA approval of the subcutaneous lecanemab (Leqembi) formulation, expanding the treatment accessibility for early Alzheimer’s disease just a week af…