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Zydus Cadila gets USFDA approval for generic seizures drug

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Cadila Healthcare on Thursday (2 April 2020) said Zydus Cadila received final approval from the US drug regulator for Lamotrigine extended-release tablets.

The pharma major said Zydus Cadila received final approval from the United States Food and Drug Administration (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 (Gujarat).

The group now has 283 approvals and has so far filed over 386 Abbreviated New Drug Application (ANDA) since the commencement of the filing process in FY 2003-04.

 

Shares of Cadila Healthcare declined 1.22% to end at Rs 263.85 on 1 April 2020. BSE and NSE are shut today on account of Ram Navami.

On a consolidated basis, the drug maker's net profit fell 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.

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First Published: Apr 02 2020 | 4:28 PM IST

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