Caplin Point Laboratories arm gets US FDA nod for Neostigmine Methylsulfate Injection

The injection is indicated for the reversal of the effects of non-depolariSing neuromuscular blocking agents (NMBAs) after surgery

Caplin Point Laboratories said its subsidiary has received approval from the US health regulator for Neostigmine Methylsulfate Injection. 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.

“Caplin Steriles Ltd (Caplin) has been granted final approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) Neostigmine Methylsulfate Injection USP in the strengths of 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1 mg/mL),” Caplin Point Laboratories said in a regulatory filing Multiple-dose vial presentations, a generic therapeutic equivalent version of (RLD), BLOXIVERZ Injection, of Exela Pharma Sciences, LLC, USA.

Quoting IQVIA (IMS Health) data, Caplin Point Laboratories said Neostigmine Methylsulfate Injection had US sales data of approximately $20 million for the 12 months ending December 2020.

PTI