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Zhejiang Poly Pharm Co., Ltd. secured FDA approval for its generic oral formulation of Brivaracetam, granting the manufacturer a competitive foothold ...
# FDA Approves ANDA Application for INVAGEN PHARMS InvaGen Pharmaceuticals has received FDA approval for ANDA218768, expanding its generic drug portf...
# FDA Approves Vanda Pharmaceuticals' New Drug Application The FDA has approved NDA 220358 for Vanda Pharmaceuticals Inc., potentially expanding the ...
# FDA Approves Avyxa Pharma's FAVLYXA (Fluorouracil) for Intravenous Use The FDA has approved Avyxa Pharma's FAVLYXA (fluorouracil) for intravenous a...
# FDA Approves AVET Lifesciences Generic Drug Application AVET Lifesciences has received FDA approval for ANDA203276, marking the company's entry int...
# FDA Approves Colchicine Generic From Micro Labs Limited Micro Labs Limited received FDA approval for its generic colchicine oral formulation, expan...
# FDA Approves Janssen's RYBREVANT FASPRO Subcutaneous Formulation The FDA has approved Janssen Biotech's RYBREVANT FASPRO (amivantamab and hyaluroni...
# FDA Approves Zydus Lifesciences Generic Drug Application Zydus Lifesciences has received FDA approval for ANDA217815, expanding the company's gener...
# FDA Approves Generic Glatiramer Acetate for Ajenat Pharmaceuticals Ajenat Pharmaceuticals LLC has received FDA approval for its generic glatiramer ...
# FDA Approves Encube Ethicals' Generic Tretinoin Topical Formulation The U.S. Food and Drug Administration has approved Encube Ethicals, Inc.'s abbr...
On February 10, 2026, Hikma announced regulatory approval for a generic drug through ANDA205057, signaling a strategic precedent for future portfolio ...
# FDA Approves Gland Pharma's Generic Zoledronic Acid Gland Pharma Limited has received FDA approval for its generic zoledronic acid intravenous form...
# FDA Approves Generic Carbidopa, Levodopa and Entacapone from Alembic Pharmaceuticals Alembic Pharmaceuticals Inc. received FDA approval for a gener...
# FDA Approves CIPLA's Generic Drug Application Cipla Limited received FDA approval for its abbreviated new drug application (ANDA 213165) on Februar...
# FDA Approves Somerset Therapeutics' Generic Rilpivirine Somerset Therapeutics, LLC has received FDA approval for its generic rilpivirine hydrochlor...
# FDA Approves Generic Difluprednate Ophthalmic from Alembic Pharmaceuticals The FDA has approved Alembic Pharmaceuticals' generic difluprednate opht...
Novitium Pharma secured FDA approval for its ANDA 219119, a milestone anticipated to accelerate revenue generation and strengthen the company's compet...
# FDA Approves Novo Nordisk's Oral Semaglutide (Wegovy) Novo Nordisk Pharmaceutical Industries, LP received FDA approval for the oral formulation of ...
# FDA Approves Generic MACITENTAN from Novugen Pharma The FDA has approved Novugen Pharma's generic version of MACITENTAN, an endothelin receptor ant...
# FDA Approves Generic Lenalidomide from Accord Healthcare Inc. Accord Healthcare Inc. received FDA approval for generic lenalidomide (ANDA218872), m...