Zydus Lifesciences bags USFDA okay for Norepinephrine Bitartrate Injection

Ahmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited), today announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to market Norepinephrine Bitartrate Injection USP,4 mg/4 mL (1 mg/mL) Single-Dose Vial.

Norepinephrine Bitartrate is indicated for restoration of blood pressure in adult patients with acute hypotensive state.

The drug will be manufactured at the group's topical injectable manufacturing facility at Jarod, India.

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Norepinephrine Bitartrate Injection USP, 1mg/1 mL had annual sales of US$ 63.8 million in the United States according to IQVIA data (IQVIA MAT May 2022). The group now has 317 approvals and has so far filed over 420* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team had earlier reported that the Zydus Cadila had received final approval from the USFDA to market Droxidopa Capsules, 100 mg, 200 mg, and 300 mg (US RLD: Northera Capsules).

Read also: Zydus Cadila secures USFDA nod for Droxidopa Capsules to treat low blood pressure

Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.

Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.

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