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Zydus Cadila gets USFDA nod to market generic cancer drug in US

The company has received final approval from the US Food and Drug Administration (USFDA) to Decitabine for Injection in the strength of 50 mg/vial single-dose vial, Zydus Cadila said in a statement.

November 20, 2021 / 03:07 PM IST
Biocon | Subsidiary Biocon Biologics, and Viatris launched interchangeable biosimilars SEMGLEE (insulin glargineyfgn) injection, a branded product, and Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product, to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes, in the US.

Biocon | Subsidiary Biocon Biologics, and Viatris launched interchangeable biosimilars SEMGLEE (insulin glargineyfgn) injection, a branded product, and Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product, to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes, in the US.

Drug firm Zydus Cadila on Saturday said it has received approval from the US health regulator to market Decitabine injection, used to treat certain types of cancers, in the American market.

The company has received final approval from the US Food and Drug Administration (USFDA) to Decitabine for Injection in the strength of 50 mg/vial single-dose vial, Zydus Cadila said in a statement.

Decitabine is used to treat myelodysplastic syndromes, certain types of blood or bone marrow cancer. The drug will be manufactured at the group’s injectables manufacturing facility, tbe drug maker said.

The Zydus group now has 326 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04, it added.
PTI
first published: Nov 20, 2021 03:07 pm

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