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Zydus Cadila gets nod from USFDA to market Parkinson’s disease drug

Drug firm Zydus Cadila on Saturday said it has received a tentative nod from the USFDA (United States Food and Drug Administration) to market Carbidopa and Levodopa extended-release capsules. The drugs are used for the treatment of symptoms of Parkinson’s disease.

This medication is used to treat the symptoms of Parkinson’s disease such as shakiness, stiffness, difficulty moving or Parkinson-like conditions, Zydus Cadila said.

The drug will be manufactured at the group’s formulation manufacturing facility at SEZ*, Ahmedabad, it added.

*SEZ: Special Economic Zone

In the past week, Zydus has received approval from the US health regulator to initiate clinical trials for its drug ‘Desidustat’ in the treatment of chemotherapy-induced anaemia (CIA).

Desidustat is a novel drug which is also currently undergoing phase-III trial for treating anaemia in chronic kidney disease patients and phase-II studies for management of COVID-19 patients.

Cadila Chairman Pankaj R Patel said CIA is a serious unmet medical need and there is a need for novel therapies to address this condition.

The group now has 295 approvals and has so far filed over 390 abbreviated new drug applications (ANDAs) with the USFDA since the commencement of its filing process, it added.

In conclusion, Approvals and ANDAs come at a time when it aims to complete the clinical trials of COVID-19 vaccine by March 2021 and is in track to mass-produce the same.

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