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# FDA Approves Generic Mexiletine Hydrochloride from Macleods Pharmaceuticals Macleods Pharmaceuticals Limited has received FDA approval for its generic mexiletine hydrochloride o…
# FDA Approves Aurobindo Pharma's Generic Cefixime Oral Formulation The U.S. FDA has approved Aurobindo Pharma Limited's abbreviated new drug application (ANDA217607) for generic …
# FDA Approves Advagen Pharma's Atomoxetine Hydrochloride for Oral Administration Advagen Pharma Ltd. has received FDA approval for its atomoxetine hydrochloride oral formulation …
# FDA Approves Generic Drug for Fresenius Kabi USA Fresenius Kabi USA received FDA approval for a generic drug formulation under ANDA219991, expanding the company's portfolio in t…
# FDA Approves Generic Drug Application for Actavis Labs FL Inc Actavis Labs FL Inc received FDA approval for abbreviated new drug application (ANDA) 208959 on March 19, 2026, pos…
Septodont Inc. has received FDA approval for the Flavalta submucosal lidocaine and epinephrine system, a launch set for March 19, 2026, which is expected to provide a competitive a…
# FDA Approves Glenmark Therapeutics' Generic Fluticasone Propionate Nasal Spray The FDA has approved Glenmark Therapeutics Inc.'s abbreviated new drug application for generic flu…
Dr. Reddy’s Laboratories Inc. announced the FDA approval of its oral Eltrombopag Olamine (ANDA219121), which is slated for March 16, 2026, and positions the company to capture mark…
# FDA Approves Generic Citalopram for Aurobindo Pharma Aurobindo Pharma Limited has received FDA approval for its generic citalopram hydrobromide oral formulation (ANDA219985), en…
# FDA Approves Generic Drug Application for Hetero Labs Hetero Labs Ltd III received FDA approval for an abbreviated new drug application (ANDA218264) on March 12, 2026, positioni…
# FDA Approves Generic Liraglutide from Biocon Pharma Inc. Biocon Pharma Inc. has received FDA approval for its generic formulation of liraglutide (ANDA215245), a widely-prescribe…
# FDA Approves Zydus Lifesciences' Generic Cevimeline Hydrochloride Zydus Lifesciences Limited has received FDA approval for its generic cevimeline hydrochloride oral formulation,…
# FDA Approves DIFGEN Pharms Generic Drug Application DIFGEN Pharms has received FDA approval for its abbreviated new drug application (ANDA 219997), potentially expanding the com…
The FDA has granted approval to YICHANG HUMANWELL for a new Abbreviated New Drug Application, extending the company’s commercial footprint in the generic sector and supporting ongo…
# FDA Approves E5 Pharma ANDA Application E5 Pharma has received FDA approval for ANDA216808, marking a significant expansion of the company's generic drug portfolio and positioni…
# FDA Approves KNACK's Generic Drug Application KNACK has received FDA approval for its abbreviated new drug application (ANDA 218675), positioning the company to capture market s…
# FDA Approves ANDA for Steranco Healthcare Steranco Healthcare has received FDA approval for an abbreviated new drug application (ANDA220281), positioning the company to expand i…
CONTRACT PHARMACAL today announced that the FDA has granted approval for its ANDA #219603, a milestone likely to boost the company's generic revenue streams as it prepares for the …
# FDA Approves Solco Healthcare's Generic Gabapentin The FDA has approved Solco Healthcare US, LLC's abbreviated new drug application for generic gabapentin oral formulation, expa…
# FDA Approves Aurobindo Pharma Generic Drug Application The U.S. Food and Drug Administration has approved Aurobindo Pharma Ltd.'s abbreviated new drug application (ANDA218459) a…