Regulatorische Updates

The FDA has approved NDA018090 for Sodium Chloride 0.45% injectable, manufactured by ICU Medical Inc.

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

FDA approved ANDA076589 submitted by Dr Reddys, covering two injectable FLUMAZENIL products, both listed with discontinued marketing status.

The FDA approved ANDA077165 for a preservative‑free granisetron hydrochloride injectable product by Dr. Reddys; the product is listed as discontinued.

The FDA has granted approval for ANDA076316, a prescription injectable sodium chloride 0.9% solution in a plastic container, submitted by GVS TM.

The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor Smith and Nephew as discontinued under ANDA087592.

FDA has approved ANDA078641 for a prescription injectable famotidine 10 mg/mL product marketed by Mylan Institutional LLC.

The FDA has granted approval for Fresenius Kabi USA’s preservative‑free OCTREOTIDE acetate injectable products under ANDA 077457, covering three dosage strengths for injection.

BioSolution received MFDS approval for the IND of its injectable osteoarthritis cell therapy, SperoQure, and will commence Phase 1/2a trials to assess its DMOAD potential.

The FDA issued an approval letter for ANDA 076484 submitted by Fresenius Kabi USA, covering two ciprofloxacin injectable products (200 mg/20 mL and 400 mg/40 mL). Both products are listed as discontinued.

The FDA has granted approval for ANDA080445, covering multiple injectable strengths of meperidine hydrochloride manufactured by Hikma Pharmaceuticals USA.

The FDA has approved ANDA078299 for Ketorolac Tromethamine injectable (15 mg/mL and 30 mg/mL) from Onesource Specialty, with labeling updates; both products are marked discontinued.