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).
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This ANDA is for 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.