FDA Approves PIRFENIDONE — Aurobindo Pharma Limited
# FDA Approves Generic Pirfenidone from Aurobindo Pharma The FDA has approved Aurobindo Pharma Limited's generic version of pirfenidone, an oral antifibrotic treatment for idiopat…
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# FDA Approves Generic Pirfenidone from Aurobindo Pharma The FDA has approved Aurobindo Pharma Limited's generic version of pirfenidone, an oral antifibrotic treatment for idiopat…
# FDA Approves Aurobindo Pharma Generic Drug Application Aurobindo Pharma Ltd has received FDA approval for its abbreviated new drug application (ANDA210386), positioning the Indi…
EXTROVIS announced the FDA approval of its ANDA application, a regulatory milestone expected to broaden its commercial portfolio and facilitate market entry into a key therapeutic …
# FDA Approves Mankind Pharma Generic Drug Application Mankind Pharma has received FDA approval for its abbreviated new drug application (ANDA220398), expanding the company's gene…
# FDA Approves Teva's Generic Glycerol Phenylbutyrate Teva Pharmaceuticals has received FDA approval for its generic formulation of glycerol phenylbutyrate, an oral medication use…
# FDA Approves Edenbridge Pharmaceuticals' Generic Atropine Sulfate Ophthalmic Formulation Edenbridge Pharmaceuticals LLC has received FDA approval for its generic atropine sulfat…
# FDA Approves Alembic Pharmaceuticals' Generic Methotrexate Sodium Injection Alembic Pharmaceuticals Inc. has received FDA approval for its generic methotrexate sodium injection …
# FDA Approves Novadoz Pharmaceuticals' Generic Glycerol Phenylbutyrate Oral Formulation Novadoz Pharmaceuticals LLC has received FDA approval for its generic oral formulation of …
Baxter Healthcare Corporation received FDA approval for its intravenous generic dexmedetomidine, a move expected to drive immediate price competition against the branded reference …
The FDA has approved the generic drug application (ANDA 210449) for Apotex, authorizing the manufacturer to launch a cost-effective alternative to the branded treatment. This appro…
ANI Pharmaceuticals, Inc. announced the receipt of FDA approval for its pimozide ANDA, granting the company access to the established antipsychotic market. This generic launch is a…
MICRO LABS has secured FDA approval for a generic substance pursuant to ANDA206371, a milestone expected to bolster the company's market share and expand its commercial footprint i…
# FDA Approves Generic Fosfomycin Tromethamine, Expanding Treatment Options for Urinary Tract Infections Aucta Pharmaceuticals, Inc. received FDA approval for its generic formulat…
Apotex Corp. has secured FDA approval for its Intravenous Adult Multiple Vitamins pharmacy bulk package, bolstering its commercial portfolio and providing the company with a key gr…
On April 9, 2026, Apotex Corp received FDA approval for a generic Adult Multiple Vitamins single-dose product, a move likely to intensify price competition within the adult multivi…
# FDA Approves Micro Labs' Generic Drug Application Micro Labs has received FDA approval for its abbreviated new drug application (ANDA218557), expanding the company's generic pha…
Hikma Pharmaceuticals USA Inc. received FDA approval for its Abbreviated New Drug Application (ANDA) covering oral Eltrombopag Olamine on April 8, 2026, positioning the company to …
Glenmark Pharmaceuticals USA announced today the approval of its generic progesterone vaginal inserts (ANDA 216363) by the FDA, a critical move to capture market share in the short…
# FDA Approves Generic Ivermectin ANDA from Ajanta Pharma USA Inc. Ajanta Pharma USA Inc. has received FDA approval for its generic ivermectin oral formulation (ANDA218509), expan…
# FDA Approves Creekwood Pharmaceuticals' Generic Nitrofurantoin for Urinary Tract Infections The FDA has approved Creekwood Pharmaceuticals LLC's generic nitrofurantoin monohydra…