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-induced nausea and vomiting, add…
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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…
Amgen announced the FDA approval of its viocumab (Repatha) for a pediatric indication on February 26, promising to expand its lipid-lowering market share against Eli Lilly's Pralue…
Cipla USA Inc announced Friday the approval of its Abbreviated New Drug Application (ANDA) for sumatriptan nasal spray, a generic version of the branded migraine treatment. This re…
Slate Run Pharmaceuticals, LLC announced the February 2021 approval of its ANDA for mycophenolic acid oral tablets, a biosimilar to the original immunosuppressant...
# 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…
The FDA has granted tentative approval to fosaprepitant dimeglumine, an intravenous antiemetic, enabling Eugia US LLC to enter the market pending final resolution of a patent dispu…
Ascend Laboratories, LLC received FDA approval Tuesday for the generic version of Fingolimod Hydrochloride (Gilenya), potentially intensifying generic competition in the autoimmune…
Amgen Inc. has received regulatory approval for [Substance Name], a pivotal development that is expected to bolster the company's balance sheet and fortify its market position in t…
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 …
# FDA Approves Generic Drug Application for Accord Healthcare Accord Healthcare received FDA approval for ANDA 214425 on November 13, 2020, expanding its generic pharmaceutical po…
Ascend Laboratories, LLC has announced the FDA approval of its tacrolimus ANDA, entering the competitive oral tacrolimus market with a potential impact on brand pricing and generic…
# FDA Approves Generic Pomalidomide; Aurobindo Pharma Enters Multiple Myeloma Market Aurobindo Pharma Limited received FDA approval for its generic pomalidomide oral formulation, …
On October 30, 2020, Natco Pharma Limited received approval from the FDA for its generic version of the oral drug pomalidomide under ANDA210111, a move that expands the manufacture…
Accord Healthcare Inc. has received FDA approval for the Abbreviated New Drug Application (ANDA207991) for oral fingolimod hydrochloride, introducing a critical manufacturing compe…
FDA has granted tentative approval to Accord Healthcare, Inc.’s ANDA for methylphenidate hydrochloride tablets, a generic version of the drug known by the brand name Ritalin, allow…
Leading Pharma, LLC received FDA approval for generic oral Leucovorin Calcium, introducing a new entrant that is expected to intensify competition and exert downward pressure on pr…