Caplin Steriles receives USFDA approval for Labetalol Hydrochloride Injection

Caplin Steriles, a subsidiary 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) Labetalol Hydrochloride Injection USP, 100 mg/20 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL) Multiple-dose Vials, a generic therapeutic equivalent version of (RLD), TRANDATE Injection, of Sebela Ireland.

Labetalol Hydrochloride Injection USP is indicated for control of blood pressure in severe hypertension. According to IQVIATM (IMS Health), Labetalol hydrochloride Injection had US sales data of approximately $6 million for the 12-month period ending June 2021.

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