Caplin Steriles gets FDA nod for Norepinephrine Bitartrate Injection


Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited has secured final approval from the United States Food and Drug Administration (FDA). The approval is for its Abbreviated New Drug Application (ANDA) Norepinephrine Bitartrate Injection USP, a generic equivalent of Hospira Inc’s LEVOPHED.

Caplin’s Drug Targets $40 Million Market

The approval comes as a key milestone for Caplin Steriles, considering the market size for Norepinephrine Bitartrate Injection. The drug is used to restore blood pressure in adult patients suffering from acute hypotensive states. According to market research by IQVIA™ (IMS Health), the drug saw US sales of approximately $40 million for the 12-month period ending in June 2023.

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Caplin Point Laboratories Eyes Expansion with FDA Approval

Caplin Steriles’ ANDA approval for Norepinephrine Bitartrate Injection 4 mg/4 mL (1 mg/mL) Single-Dose Vial positions the company and its parent, Caplin Point Laboratories, for significant growth. This USFDA approval could pave the way for the company to expand its portfolio and capture a share of a lucrative market. This final approval for the generic therapeutic equivalent of LEVOPHED underscores Caplin Steriles’ commitment to meeting high regulatory standards and patient needs.

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With this FDA approval, Caplin Steriles and Caplin Point Laboratories are poised to make a notable impact on the US healthcare market, particularly in the domain of drugs used for restoring blood pressure in acute hypotensive states.

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