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...
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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 ...
ACCORD
FDA Approves Unknown Drug — ACCORD HLTHCARE
# FDA Approves Generic Drug Application for Accord Healthcare Accord Healthcare received FDA approval for ANDA 214425 on November 13, 2020, expanding...
Aurobindo
FDA Approves POMALIDOMIDE — Aurobindo Pharma Limited
# FDA Approves Generic Pomalidomide; Aurobindo Pharma Enters Multiple Myeloma Market Aurobindo Pharma Limited received FDA approval for its generic p...
Natco
FDA Approves POMALIDOMIDE — Natco Pharma Limited
On October 30, 2020, Natco Pharma Limited received approval from the FDA for its generic version of the oral drug pomalidomide under ANDA210111, a mov...
Leading
FDA Approves LEUCOVORIN CALCIUM — Leading Pharma, LLC
Leading Pharma, LLC received FDA approval for generic oral Leucovorin Calcium, introducing a new entrant that is expected to intensify competition and...
Gilead
FDA Approves VEKLURY — Gilead Sciences, Inc.
The FDA’s approval of Gilead Sciences, Inc.’s intravenous remdesivir (VEKLURY) marks a significant milestone for the company’s antiviral portfolio, po...
Harmony
FDA Approves WAKIX — Harmony Biosciences, LLC
# FDA Approves Harmony Biosciences' WAKIX for Narcolepsy Treatment Harmony Biosciences announced FDA approval of WAKIX (pitolisant hydrochloride), an...
Lifestar
FDA Approves ACETAZOLAMIDE — Lifestar Pharma LLC
# FDA Approves Lifestar Pharma's Generic Acetazolamide The U.S. Food and Drug Administration has approved Lifestar Pharma LLC's abbreviated new drug ...