Caplin Steriles gets USFDA approval for Neostigmine Methylsulfate Injection

Caplin Steriles, a subsidiary company of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Neostigmine Methylsulfate Injection USP, 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1 mg/mL), Multiple-Dose vial presentations, a generic therapeutic equivalent version of (RLD), BLOXIVERZ Injection, of Exela Pharma Sciences, LLC.

Neostigmine Methylsulfate Injection is a cholinesterase inhibitor and is indicated for the reversal of the effects of non-depolarising neuromuscular blocking agents (NMBAs) after surgery. According to IQVIA (IMS Health), Neostigmine Methylsulfate Injection had US sales data of approximately $20 million for the 12-month period ending Dec 2020.