NANG
FDA Approves Unknown Drug — NANG KUANG PHARM CO
# 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 gen...
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Accord
FDA Approves ARGATROBAN — Accord Healthcare Inc.
# FDA Approves Accord Healthcare's Argatroban Injectable, Expanding Anticoagulant Market Accord Healthcare Inc. received FDA approval for its intrave...
NOVO
FDA Approves Unknown Drug — NOVO
Novo Nordisk announced the U.S. approval of a new medication today, a development that is poised to significantly impact the competitive landscape for...
AJANTA
FDA Approves Unknown Drug — AJANTA PHARMA LTD
Ajanta Pharma’s recent FDA approval for ANDA 212943 positions the company to expand its footprint in the U.S. therapeutic market, potentially driving ...
Merck
FDA Approves NOXAFIL — Merck Sharp & Dohme LLC
# FDA Approves Merck's NOXAFIL (Posaconazole) Oral Formulation Merck Sharp & Dohme LLC has received FDA approval for an oral formulation of NOXAFIL (...
Alkermes,
FDA Approves LYBALVI — Alkermes, Inc.
# FDA Approves Alkermes' LYBALVI for Schizophrenia and Bipolar Disorder Treatment Alkermes, Inc. received FDA approval for LYBALVI (olanzapine and sa...
LGM
FDA Approves Unknown Drug — LGM PHARMA
LGM Pharma announced the approval of its ANDA for a leading antihistamine, marking a significant milestone that positions the company to capitalize on...
Camber
FDA Approves GABAPENTIN — Camber Pharmaceuticals, Inc.
# FDA Approves Gabapentin Generic from Camber Pharmaceuticals The FDA has approved Camber Pharmaceuticals' abbreviated new drug application for gener...
MYLAN
FDA Approves Unknown Drug — MYLAN TECH VIATRIS
Viatris received an FDA approval for an Abbreviated New Drug Application on May 3, 2021, positioning the company for potential market entry and revenu...
ADC
FDA Approves ZYNLONTA — ADC Therapeutics America, Inc.
# FDA Approves ADC Therapeutics' ZYNLONTA for Relapsed or Refractory Diffuse Large B-Cell Lymphoma ADC Therapeutics America, Inc. received FDA approv...
Encube
FDA Approves CLINDAMYCIN PHOSPHATE — Encube Ethicals, Inc.
# FDA Approves Encube Ethicals' Generic Clindamycin Phosphate Gel Encube Ethicals, Inc. received FDA approval for its generic clindamycin phosphate g...
Natco
FDA Approves EVEROLIMUS — Natco Pharma Limited
# FDA Approves Generic Everolimus from Natco Pharma Natco Pharma Limited received FDA approval for its generic version of everolimus, an oral immunos...
Avenacy,
FDA Approves FOSAPREPITANT — Avenacy, LLC
Avenacy, LLC won FDA approval on Wednesday to sell the generic version of Fosaprepitant Dimeglumine, an IV anti-emetic used to prevent chemotherapy-in...
Alvogen
FDA Approves HYDROCODONE BITARTRATE — Alvogen Inc.
Alvogen Inc. secured FDA approval for ANDA 208269 to market generic Hydrocodone Bitartrate oral tablets, positioning the company to influence market p...
Sentynl
FDA Approves NULIBRY — Sentynl Therapeutics, Inc.
# FDA Approval Newswire **Sentynl Therapeutics Receives FDA Approval for NULIBRY (Fosdenopterin Hydrobromide), Expanding Treatment Options in Rare Di...
Amgen
FDA Approves REPATHA — Amgen USA Inc.
Amgen announced the FDA approval of its viocumab (Repatha) for a pediatric indication on February 26, promising to expand its lipid-lowering market sh...
Dr.
FDA Approves VIGABATRIN — Dr. Reddys Laboratories Inc.,
# FDA Approves Dr. Reddy's Laboratories Vigabatrin Generic, Expanding Market Competition Dr. Reddy's Laboratories Inc. has received FDA approval for ...
Sigmapharm
FDA Approves ASENAPINE — Sigmapharm Laboratories, LLC
Sigmapharm Laboratories secured FDA approval for its generic, sublingual Asenapine tablets, a development expected to increase generic market penetrat...
Dr.
FDA Approves CAPECITABINE — Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited received FDA approval for its generic capecitabine, an oral chemotherapy agent, strengthening its position in the U.S...
Ingenus
FDA Approves SCOPOLAMINE — Ingenus Pharmaceuticals, LLC
# FDA Approves Ingenus Pharmaceuticals' Generic Scopolamine Transdermal Patch Ingenus Pharmaceuticals, LLC has received FDA approval for its generic ...