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# FDA Approves Generic Glycerol Phenylbutyrate; Zydus Pharmaceuticals Entry Expected to Intensify Competition The FDA has granted approval to Zydus Pharmaceuticals USA Inc. for a …
SciGen Pharmaceuticals is positioned for potential revenue growth and market entry following the FDA approval of its ANDA, a regulatory clearance expected to drive investor optimis…
# FDA Approves Anthea Pharma's Generic Bupivacaine Hydrochloride for Epidural Use Anthea Pharma Private Limited received FDA approval for its generic bupivacaine hydrochloride epi…
SHUANGCHENG has received FDA approval for ANDA 219973, marking a strategic entry into the U.S. market and solidifying the company's ability to generate immediate revenue through ma…
The FDA approved Unknown Drug from OMSAV PHARMA under application ANDA218093 on 2026-04-22.
# FDA Approves Apotex Generic Drug Application Apotex received FDA approval for ANDA210456 on April 21, 2026, marking another addition to the Canadian manufacturer's generic portf…
# FDA Approves Sandoz Generic Drug Application Sandoz received FDA approval for an abbreviated new drug application (ANDA216068) on April 20, 2026, potentially expanding the compa…
# FDA Approves Merck's IDVYNSO (Doravirine/Islatravir) for HIV Treatment Merck Sharp & Dohme LLC has received FDA approval for IDVYNSO, an oral combination therapy featuring dorav…
# 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…