Regulatory Updates
Sep 24, 2026•1 min read
FDA approves PHOTOFRIN (Porfimer Sodium) injection – NDA020451
FDA granted approval for PHOTOFRIN, a porfimer sodium injectable marketed by Pinnacle Biologics, under application NDA020451.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Artesunate Injection (NDA 213036) – Orphan Drug Designation
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.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 077139 for Teva’s Intravenous Carboplatin Injectable Products
The FDA has approved ANDA 077139 for Teva Pharm USA’s carboplatin injectable products, with multiple supplemental approvals covering labeling and manufacturing.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Baxter Potassium Chloride in Dextrose & Sodium Chloride Injection (NDA018008)
The FDA has approved Baxter Healthcare's intravenous potassium chloride, dextrose and sodium chloride injection (NDA018008) across several dosage strengths.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Grants ANDA214126 Approval for SUGAMMADEX SODIUM Intravenous Solutions
The FDA has approved Teva Pharm USA's ANDA214126 for two intravenous SUGAMMADEX SODIUM solutions (200 mg/2 mL and 500 mg/5 mL).
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA212957 for Fosaprepitant Dimeglumine (Discontinued Product)
The FDA granted approval (status AP) for ANDA212957 submitted by Chartwell Rx for the intravenous powder Fosaprepitant Dimeglumine, which is listed as discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
CAPLIN Paricalcitol IV Solutions Discontinued – FDA ANDA204910
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.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves VARUBI (rolapitant) Intravenous Emulsion under NDA 208399
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.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA090018 for ZoleDRonic Acid Injectable (Discontinued)
Sun Pharma Global received FDA approval (ANDA090018) for a 4 mg/vial intravenous ZoleDRonic Acid injectable, currently listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves FLUMAZENIL (ANDA076955) for Intravenous Use
The FDA has approved the injectable drug FLUMAZENIL (application ANDA076955) from Fresenius Kabi USA, available in two IV strengths.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA077997 for Caffeine Citrate Intravenous Solution
The FDA has granted approval for ANDA077997, an intravenous caffeine citrate solution manufactured by Fresenius Kabi USA, now listed as a prescription drug.
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Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves TECHNESCAN HDP (NDA018321) for Intravenous Use
The FDA has approved TECHNESCAN HDP (NDA018321), a technetium‑99m oxidronate injection manufactured by Curium US LLC.