FDA Approves DAPTOMYCIN — Meitheal Pharmaceuticals Inc.
Meitheal Pharmaceuticals Inc. secured FDA approval for its intravenous Daptomycin, positioning the company to capitalize on the high-value antibiotic market and potentially capture…
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Meitheal Pharmaceuticals Inc. secured FDA approval for its intravenous Daptomycin, positioning the company to capitalize on the high-value antibiotic market and potentially capture…
# FDA Approves Generic Oxcarbazepine for Chartwell RX Chartwell RX, LLC received FDA approval for its generic oxcarbazepine oral formulation, expanding the competitive generic ant…
Sun Pharmaceutical Industries, Inc. announced the FDA approval of its ANDA for levophenanol tartrate oral tablets, following the loss of patents protecting the previous brand. This…
# FDA Approves Generic Drug Application for NANG KUANG PHARM CO The FDA has approved ANDA 204329 for Nang Kuang Pharm Co, expanding the company's generic drug portfolio and positi…
On June 15, 2021, Ascend Laboratories, LLC received FDA approval for its Abbreviated New Drug Application #214930, introducing a generic version of Buprenorphine and Naloxone in th…
# FDA Approves Accord Healthcare's Argatroban Injectable, Expanding Anticoagulant Market Accord Healthcare Inc. received FDA approval for its intravenous argatroban formulation (N…
Novo Nordisk announced the U.S. approval of a new medication today, a development that is poised to significantly impact the competitive landscape for its specific therapeutic clas…
Ajanta Pharma’s recent FDA approval for ANDA 212943 positions the company to expand its footprint in the U.S. therapeutic market, potentially driving revenue growth and enhancing i…
# FDA Approves Merck's NOXAFIL (Posaconazole) Oral Formulation Merck Sharp & Dohme LLC has received FDA approval for an oral formulation of NOXAFIL (posaconazole), potentially exp…
# FDA Approves Alkermes' LYBALVI for Schizophrenia and Bipolar Disorder Treatment Alkermes, Inc. received FDA approval for LYBALVI (olanzapine and samidorphan), a novel oral combi…
LGM Pharma announced the approval of its ANDA for a leading antihistamine, marking a significant milestone that positions the company to capitalize on the commingling of volume and…
# FDA Approves Gabapentin Generic from Camber Pharmaceuticals The FDA has approved Camber Pharmaceuticals' abbreviated new drug application for generic gabapentin oral formulation…
Viatris received an FDA approval for an Abbreviated New Drug Application on May 3, 2021, positioning the company for potential market entry and revenue growth in the generic pharma…
# FDA Approves ADC Therapeutics' ZYNLONTA for Relapsed or Refractory Diffuse Large B-Cell Lymphoma ADC Therapeutics America, Inc. received FDA approval for ZYNLONTA (loncastuximab…
Bionpharma Inc. announced the approval of the generic drug atovaquone, allowing the company to enter new markets and strengthen its portfolio of accessible therapies for blood and …
The U.S. Food and Drug Administration has approved dasiglucagon (ZEGALOGUE) from Novo Nordisk for the emergency treatment of severe hypoglycemia caused by insulin treatment, creati…
# FDA Approves Encube Ethicals' Generic Clindamycin Phosphate Gel Encube Ethicals, Inc. received FDA approval for its generic clindamycin phosphate gel 1% (ANDA212438), a topical …
Leading Pharma, LLC announced the FDA approval of its ANDA for doxepin hydrochloride on March 9, 2021, enabling the launch of this oral anticholinergic treatment. The approval is p…
# FDA Approves Generic Everolimus from Natco Pharma Natco Pharma Limited received FDA approval for its generic version of everolimus, an oral immunosuppressant and cancer therapeu…
Amneal Pharmaceuticals has received FDA approval for generic drug ANDA211374, a development that positions the company to capture market share amidst ongoing supply chain constrain…