FDA Approves Unknown Drug — JANSSEN PRODS
# FDA Approves Janssen Product, Expanding Company's Portfolio Janssen Products received FDA approval for a new therapeutic agent under NDA 220092, potentially strengthening the ph…
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# FDA Approves Janssen Product, Expanding Company's Portfolio Janssen Products received FDA approval for a new therapeutic agent under NDA 220092, potentially strengthening the ph…
# FDA Approves Ascendis Pharma's YUVIWEL (navepegritide), Marking Entry Into Growth Hormone Deficiency Market Ascendis Pharma Endocrinology, Inc. received FDA approval for YUVIWEL…
# FDA Approves Caplin Steriles' Intravenous Desmopressin Acetate Caplin Steriles Limited has received FDA approval for its generic intravenous desmopressin acetate formulation (AN…
Macleods Pharmaceuticals Limited announced the FDA’s approval of its generic Diltiazem Hydrochloride oral tablets on February 27, 2026, facilitating the company’s expansion into th…
# FDA Approves ANDA for SinoTherapeutics Inc SinoTherapeutics Inc has received FDA approval for ANDA220454, marking the company's entry into the generic drug market and positionin…
# FDA Approves Viona Pharmaceuticals' Generic Dapsone Viona Pharmaceuticals Inc. received FDA approval for its generic dapsone oral formulation, expanding treatment options for pa…
# FDA Approves Zydus Lifesciences' Generic Ivermectin Oral Formulation Zydus Lifesciences Limited received FDA approval for its generic ivermectin oral formulation, expanding the …
# FDA Approves Aurobindo Pharma's Generic Everolimus, Expanding Competitive Landscape for Immunosuppressant Market The U.S. Food and Drug Administration has approved Aurobindo Pha…
# FDA Approves Dr. Reddy's Generic Drug Application Dr. Reddy's Laboratories has received FDA approval for ANDA220315, marking another addition to the company's generic drug portf…
# FDA Approves APPCO's Generic Drug Application APPCO has received FDA approval for an abbreviated new drug application (ANDA 220329), expanding its generic pharmaceutical portfol…
# FDA Approves Generic Cetirizine Hydrochloride for Advagen Pharma Ltd. Advagen Pharma Ltd. has received FDA approval for its generic cetirizine hydrochloride oral formulation (AN…
# FDA Approves ANDA for Yichang Humanwell The FDA has approved ANDA219518 for Yichang Humanwell, marking the company's entry into the U.S. generic drug market and potentially incr…
# FDA Approves Generic Brivaracetam Intravenous Formulation Micro Labs Limited has received FDA approval for a generic intravenous brivaracetam formulation (ANDA214880), marking a…
# FDA Approves New Generic Drug Application for Centaur Pharmaceuticals The FDA has approved ANDA220470 for Centaur Pharmaceuticals PVT, expanding the company's portfolio and pote…
# FDA Approves Brivaracetam Injection Generic, Expanding Market Competition PAI Pharma has received FDA approval for its generic brivaracetam injection, an intravenous formulation…
# FDA Approves Generic Brivaracetam Oral Solution by Florida Pharmaceutical Products Florida Pharmaceutical Products, LLC has received FDA approval for a generic version of brivar…
Zhejiang Poly Pharm Co., Ltd. secured FDA approval for its generic oral formulation of Brivaracetam, granting the manufacturer a competitive foothold in the neurological market and…
# FDA Approves ANDA Application for INVAGEN PHARMS InvaGen Pharmaceuticals has received FDA approval for ANDA218768, expanding its generic drug portfolio and positioning the compa…
# FDA Approves Vanda Pharmaceuticals' New Drug Application The FDA has approved NDA 220358 for Vanda Pharmaceuticals Inc., potentially expanding the company's product portfolio an…
# FDA Approves Avyxa Pharma's FAVLYXA (Fluorouracil) for Intravenous Use The FDA has approved Avyxa Pharma's FAVLYXA (fluorouracil) for intravenous administration, marking the com…