Calendar

Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30 — Reason: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. — Status: Completed

full page →fda recalls ↗

Mar 5, 2025recall531d agoTurbare Manufacturing recall (Cls II)Shanghai Henlius Biotech Inc

Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01. — Reason: Lack of Assurance of Sterility: due to a quality control process deviation. During an internal quality assurance review, an Acceptable Quality Limit (AQL) inspection was not conducted on a statistically sound number of samples. This may result in the inability to assure that the impacted products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess and may lead to products of unacceptable quality. — Status: Completed

full page →fda recalls ↗

Mar 5, 2025recall531d agoWuxi Medical lnstrument Factory Co., Ltd. recall (Cls II)

ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01. — Reason: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. — Status: Ongoing

full page →fda recalls ↗

Mar 6, 2025approval530d agoFUROSCIX (FUROSEMIDE) — FDA approvalFurosemide Sun

Sponsor: SCPHARMACEUTICALS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →Furosemide Sun →fda approvals ↗

Mar 6, 2025approval530d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Mar 6, 2025approval530d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Mar 6, 2025approval530d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Mar 7, 2025approval529d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 7, 2025approval529d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 7, 2025approval529d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

Mar 7, 2025approval529d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Mar 7, 2025approval529d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

Mar 7, 2025approval529d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

Mar 7, 2025approval529d agoOMLYCLO (OMALIZUMAB-IGEC) — FDA approvalomalizumab biosimilar

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION

full page →omalizumab biosimilar →fda approvals ↗

Mar 7, 2025approval529d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗

Mar 7, 2025approval529d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

Week of Mar 10, 2025

Mar 10, 2025approval526d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 10, 2025approval

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