Actualités réglementaires

FDA granted approval for PHOTOFRIN, a porfimer sodium injectable marketed by Pinnacle Biologics, under application NDA020451.

The FDA granted approval for artesunate 110 mg/vial for intravenous use under NDA 213036, an orphan-designated new molecular entity, with labeling updates through 2025.

The FDA has approved ANDA 077139 for Teva Pharm USA’s carboplatin injectable products, with multiple supplemental approvals covering labeling and manufacturing.

The FDA has approved Baxter Healthcare's intravenous potassium chloride, dextrose and sodium chloride injection (NDA018008) across several dosage strengths.

The FDA has approved Teva Pharm USA's ANDA214126 for two intravenous SUGAMMADEX SODIUM solutions (200 mg/2 mL and 500 mg/5 mL).

The FDA granted approval (status AP) for ANDA212957 submitted by Chartwell Rx for the intravenous powder Fosaprepitant Dimeglumine, which is listed as discontinued.

FDA records indicate CAPLIN's paricalcitol intravenous solutions (product numbers 001‑003) are discontinued, with original ANDA204910 approved in 2016 and labeling updates in 2024.

VARUBI, an intravenous rolapitant hydrochloride emulsion by TERSERA, received FDA approval (NDA 208399) with original submission in 2017 and labeling updates in 2018 and 2020; marketing status is discontinued.

Sun Pharma Global received FDA approval (ANDA090018) for a 4 mg/vial intravenous ZoleDRonic Acid injectable, currently listed as discontinued.

The FDA has approved the injectable drug FLUMAZENIL (application ANDA076955) from Fresenius Kabi USA, available in two IV strengths.

The FDA has granted approval for ANDA077997, an intravenous caffeine citrate solution manufactured by Fresenius Kabi USA, now listed as a prescription drug.

The FDA has approved TECHNESCAN HDP (NDA018321), a technetium‑99m oxidronate injection manufactured by Curium US LLC.