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Caplin Steriles receives USFDA final approval for Verapamil Hydrochloride injection USP

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Caplin Point Laboratories announced that its wholly owned subsidiary, Caplin Steriles, has been been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Verapamil Hydrochloride injection USP, 5 mg/2 mL (2.5 mg/mL) and 10 mg/4 mL (2.5 mg/mL) Single-dose vial, a generic therapeutic equivalent version of (RLD), Isoptin Injection, 2.5 mg/mL, of Mt.

Adams Technologies LLC.

According to IQVIATM (IMS Health), Verapamil Hydrochloride injection USP had US sales data of approximately US$28 million for the 12-month period ending Dec 2019. Verapamil Hydrochloride is a calcium channel blocker used in the treatment of cardiac conditions such as high blood pressure, arrhythmias and angina.

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First Published: Thu, March 26 2020. 11:46 IST