Drug agency Zydus Cadila on Saturday stated it has obtained tentative nod from the US health regulator to market Carbidopa and Levodopa extended-release capsules, used for the therapy of signs of Parkinson’s disease, within the US market.
The corporate has obtained tentative approval from the US 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 will probably be manufactured on the group’s formulation manufacturing facility at SEZ, Ahmedabad, it added.
This treatment is used to deal with the signs of Parkinson’s disease resembling shakiness, stiffness, problem transferring or Parkinson-like situations, Zydus Cadila stated.
The group now has 295 approvals and has up to now filed over 390 abbreviated new drug purposes (ANDAs) because the graduation of its submitting course of, it added.