It was reported on Tuesday that US-based Nephron Pharmaceuticals Corporation has received approval from US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application of Ketorolac Tromethamine Injection USP, 60mg/2mL (30mg/mL) in single-dose vials.
The vials are prepared from polypropylene plastic with a 'luer lock' interface for needle-free dosing and made using Blow-Fill-Seal technology.
The product has become one of the first Abbreviated New Drug Application-approved non-respiratory generic medications developed by the company as it aims to grow, with it also receiving USFDA approval for Sodium Chloride IV Bags earlier this year.
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