FDA Grants Multiple Approvals and Fast Track Status to Amphastar, Kamada and NRx

The U.S. Food and Drug Administration issued a series of regulatory green lights to small and mid-cap drug developers on 8–11 August, covering new medicines, manufacturing infrastructure and an expedited review pathway. Amphastar Pharmaceuticals won full approval for Iron Sucrose Injection, USP, expanding the company’s injectable portfolio in the treatment of iron-deficiency anemia. Kamada secured FDA clearance for its new plasma collection center in Houston, a milestone that supports the Israeli company’s U.S. plasma-derived therapeutics program. Separately, the agency granted Fast Track status to NRx Pharmaceuticals’ NRX-100, an intravenous ketamine formulation aimed at reducing suicidal ideation in patients with depression, including bipolar disorder. The designation is intended to speed the drug’s development and review, reflecting FDA’s view that the therapy could address an unmet medical need. PharmaTher Holdings announced that the FDA approved its ketamine product KETARx on 8 August for use in surgical pain management, positioning the Toronto-based firm to enter a global ketamine market projected to grow rapidly over the next decade.