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Zydus Cadila gets tentative US FDA approval for generic diabetes drug

Drug firm Zydus Cadila said it has received approval from the US health regulator to market diabetes drug, Empagliflozin and Linagliptin tablets, in the US market

Zydus Cadila | US FDA | Diabetes drug

Press Trust of India  |  New Delhi 

pharmacy, drugs, medicine, pharma companies, pharmaceuticals, vaccine, coronavirus, covid, testing

Drug firm on Wednesday said it has received approval from the US health regulator to market diabetes drug, Empagliflozin and Linagliptin tablets, in the US market.

The company has received tentative approval from the US Food and Drug Administration (USFDA) to market its generic product, said in a statement.

The company has received approval for the product in the strengths of 10 mg/5 mg and 25 mg/5 mg, it added.

This medication contains a combination of Empagliflozin and Linagliptin, oral diabetes medicines that help control blood sugar levels.

The drug is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Zydus said the drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad.

The group now has 299 approvals and has so far filed over 390 abbreviated new drug applications (ANDAs) since the commencement of filing process in 2003-04, it added.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Wed, September 09 2020. 15:48 IST