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Caplin Steriles receives USFDA approval for Prochlorperazine Edisylate Injection

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Caplin Steriles (Caplin), a Subsidiary Company 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) Prochlorperazine Edisylate Injection USP, 10 mg/2 mL (5 mg/mL) Vials presentations, a generic therapeutic equivalent version of (RLD), COMPAZINE Injection, of SmithKlineBeecham Corporation, USA.

Prochlorperazine Edisylate Injection is an antiemetic and is indicated for the control of severe nausea and vomiting. According to IQVIATM (IMS Health), Prochlorperazine Edisylate Injection had US sales data of approximately $17 million for the 12-month period ending Dec 2020.

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First Published: Apr 23 2021 | 1:03 PM IST

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