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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…
# 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…
# FDA Approves Encube Ethicals' Generic Clindamycin Phosphate Gel Encube Ethicals, Inc. received FDA approval for its generic clindamycin phosphate gel 1% (ANDA212438), a topical …
# 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…
Avenacy, LLC won FDA approval on Wednesday to sell the generic version of Fosaprepitant Dimeglumine, an IV anti-emetic used to prevent chemotherapy-induced nausea and vomiting, add…
Alvogen Inc. secured FDA approval for ANDA 208269 to market generic Hydrocodone Bitartrate oral tablets, positioning the company to influence market pricing within the opioid segme…
# FDA Approval Newswire **Sentynl Therapeutics Receives FDA Approval for NULIBRY (Fosdenopterin Hydrobromide), Expanding Treatment Options in Rare Disease Market** The FDA approv…
# FDA Approves Dr. Reddy's Laboratories Vigabatrin Generic, Expanding Market Competition Dr. Reddy's Laboratories Inc. has received FDA approval for its generic vigabatrin oral fo…
Sigmapharm Laboratories secured FDA approval for its generic, sublingual Asenapine tablets, a development expected to increase generic market penetration and exert competitive pric…
Dr. Reddy's Laboratories Limited received FDA approval for its generic capecitabine, an oral chemotherapy agent, strengthening its position in the U.S. oncology market and expandin…
# FDA Approves Ingenus Pharmaceuticals' Generic Scopolamine Transdermal Patch Ingenus Pharmaceuticals, LLC has received FDA approval for its generic scopolamine transdermal patch …