Caplin Steriles receives USFDA final approval for Phenylephrine Hydrochloride injection

Caplin Point Laboratories announced that its subsidiary, Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phenylephrine Hydrochloride injection USP, 10 mg/mL Single-Dose Vial, 50 mg/5 mL (10mg/mL) Pharmacy Bulk Package, and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package, a generic therapeutic equivalent version of (RLD), VAZCULEP Injection, of Avadel Legacy Pharmaceuticals LLC.

According to IQVIATM (IMS Health), Phenylephrine Hydrochloride injection USP had US sales data of approximately $45 million for the 12-month period ending Mar 2020. Caplin Steriles Limited, has developed and filed 17 ANDAs on its own and with partners, with 9 approvals so far.

Phenylephrine Hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

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