October 26, 2020

Zydus Cadila will get tentative nod from USFDA to market Parkinson’s illness drug



Drug agency Zydus Cadila on Saturday stated it has acquired tentative nod from the US well being regulator to market Carbidopa and Levodopa extended-release capsules, used for the remedy of signs of Parkinson’s illness, within the US market.

The corporate has acquired tentative approval from the USA Meals and Drug Administration (USFDA) to market the capsules within the strengths of 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg, Zydus Cadila stated in a press release.

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

This remedy is used to deal with the signs of Parkinson’s illness resembling shakiness, stiffness, problem transferring or Parkinson-like situations, Zydus Cadila stated.

The group now has 295 approvals and has to date filed over 390 abbreviated new drug purposes (ANDAs) because the graduation of its submitting course of, it added.