Caplin Steriles receives USFDA final approval for Sodium Nitroprusside injection

Caplin Steriles, the wholly owned 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) Sodium Nitroprusside injection, 50 mg/2 ml (25 mg/ml) Vial, a generic therapeutic equivalent version of NITROPRESS (Sodium Nitroprusside) 50 mg/vial of Hospira Worldwide, INC .

According to IQVIA (IMS Health), Sodium Nitroprusside had US sales data of approximately $8 million for the 12-months period ending March 2019. Caplin Steriles , has developed and filed 13 ANDAs on its own and with partners, with 6 approvals so far.

Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute congestive heart failure.

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