Caplin Point Laboratories arm gets USFDA nod for nausea control drug

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New Delhi, Apr 23 (PTI) Caplin Point Laboratories on Friday said its subsidiary has received approval from the US health regulator for Prochlorperazine Edisylate Injection which is indicated to control severe nausea and vomiting.

The approved a generic therapeutic equivalent version of Compazine Injection of SmithKlineBeecham Corporation, USA.

'Caplin Steriles Ltd... has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Prochlorperazine Edisylate Injection USP, 10 mg/2 mL (5 mg/mL) vials presentations,' Caplin Point Laboratories said in a regulatory filing.

Prochlorperazine Edisylate Injection is an antiemetic and is indicated for the control of severe nausea and vomiting.

Quoting IQVIA (IMS Health) data, Caplin Point Laboratories Prochlorperazine Edisylate Injection had US sales data of approximately USD 17 million for the 12-month period ending Dec 2020.

C C Paarthipan, Chairman of Caplin Point Laboratories, said the company has received three product approvals within a short period of time.

'All input materials for the launches have been secured and we're working on the launch batches shortly,” he added. PTI SVK ANS ANS ANS