Cadila Healthcare gets USFDA approval for generic type 2 diabetes drug

Cadila Healthcare said Zydus Cadila has received tentative approval from the US drug regulator to market Empagliflozin tablets, in the strengths of 10 mg and 25 mg.

The medication is used together with diet and exercise to improve blood sugar control in adults with Type 2 diabetes mellitus. It is also used to reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and established cardiovascular disease.

The drug will be manufactured at the group's manufacturing facility at SEZ, Ahmedabad, Cadila Healthcare said in a statement on Friday 10 April 2020.

The group now has 286 approvals and has so far filed over 386 ANDAs since the commencement of the filing process in FY 2003-04, it added.

On 9 April 2020, Zydus Cadila received final approval from the United States Food & Drug Administration (USFDA) to market Imatinib Mesylate tablets (100 mg and 400 mg). This medication is used to treat certain types of leukemia (blood cancer), bone marrow disorders, skin cancer and tumors of the stomach and digestive system. The drug will be manufactured at the its formulation manufacturing facility at the SEZ, in Ahmedabad, Gujarat.

On 7 April 2020, the company got the final nod from the US drug regulator to market Perphenazine tablets in multiple strengths. This medication is indicated for the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. The drug will be manufactured at the group's formulation manufacturing facility at Baddi, Himachal Pradesh.

On 2 April 2020, the drug major received the final clearance from USFDA to market Lamotrigine extended-release tablets USP in multiple strengths of 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg. The medication is indicated for treating certain types of seizures. It will be manufactured at the group manufacturing facility at SEZ, Ahmedabad in Gujarat.

On a consolidated basis, the drug maker's net profit tanked 26.54% to Rs 375.18 crore on a 0.52% rise in net sales to Rs 3,534.50 crore in Q3 December 2019 Q3 December 2018.

Cadila Healthcare is a pharmaceutical company based in India.

Shares of Cadila Healthcare rose 0.21% to Rs 350.70 on Thursday, 9 April 2020. The market was shut on Friday, 10 April, for a public holiday.

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