Caplin Point Laboratories gets FDA approval for Prochlorperazine Edisylate Injection

Caplin Point Laboratories said that its subsidiary Caplin Steriles has secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Prochlorperazine Edisylate Injection USP, 10 mg/2 mL (5 mg/mL) Vials presentations.

Prochlorperazine Edisylate Injection is a generic therapeutic equivalent version of (RLD), COMPAZINE Injection, manufactured by SmithKlineBeecham.

It is an antiemetic indicated for the control of severe nausea and vomiting.

C. C. Paarthipan – Chairman of Caplin Point Laboratories said: “We’re glad to receive 3 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.”