Instant Report

Date: 23-Apr-2021

Caplin Steriles Gets US FDA Approval For Generic Bloxiverz Injection

Caplin Steriles Limited (Caplin), a subsidiary company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (FDA) 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, USA.

Neostigmine methylsulfate injection is a cholinesterase inhibitor and is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.

According to IQVIA (IMS Health), neostigmine methylsulfate injection had US sales data of approximately US$ 20 million for the 12-month period ending December 2020.