Regulatorische Updates
19. Sept. 2026•1 Min. Lesezeit
FDA Approves Primaquine Phosphate (NDA008316)
The FDA has approved Primaquine Phosphate, an oral prescription tablet (NDA008316) from Sanofi‑Aventis U.S. LLC, with recent labeling updates in 2025.
Regulatorische Updates
17. Sept. 2026•1 Min. Lesezeit
FDA Approves Sanofi Aventis NDA012283 for HYGROTON Chlorthalidone Tablets
The FDA has granted approval (NDA012283) for Sanofi Aventis’s HYGROTON oral tablets containing chlorthalidone 25 mg and 50 mg, previously listed as discontinued but not withdrawn for safety reasons.
Regulatorische Updates
10. Sept. 2026•1 Min. Lesezeit
FDA Approves ACTHAR Injectable (NDA007504)
The FDA’s NDA007504 approval for ACTHAR injectable (25 UNITS/VIAL and 40 UNITS/VIAL) by Sanofi Aventis includes multiple priority labeling supplements, though the products are listed as discontinued.
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
FDA Approves SANOFI AVENTIS US's ORNIDYL Injection (Eflornithine Hydrochloride) – NDA019879
The FDA granted priority approval for SANOFI AVENTIS US's ORNIDYL injectable (Eflornithine Hydrochloride 200 mg/mL) under NDA019879, with orphan drug designation.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
FDA Approves Sanofi's Subcutaneous Sarclisa Escena for Multiple Myeloma
Sanofi's subcutaneous formulation of Sarclisa, Sarclisa Escena, received FDA approval, becoming the first injectable oncology drug deliverable via on-body injector.
Regulatorische Updates
26. Aug. 2026•1 Min. Lesezeit
Sanofi’s Genzyme Ireland unit receives FDA Form 483, faces further reprimand
FDA inspectors issued a Form 483 to Sanofi’s Genzyme Ireland after a 2026 site visit, prompting additional regulatory reprimand.