BackZydus Cadila gets tentative nod from USFDA for Parkinson's treatment capsule
The approval by the US Food and Drug Administration is for Carbidopa and Levodopa extended-release capsules in the strengths of 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg, Cadila Healthcare said in a regulatory filing.
PremiumNEW DELHI : Domestic pharma major Zydus Cadila, part of Cadila Healthcare group, on Monday said it has received tentative approval from the US health regulator for its generic version of Parkinson’s disease treatment drug Carbidopa and Levodopa extended-release capsules.
The approval by the US Food and Drug Administration is for Carbidopa and Levodopa extended-release capsules in the strengths of 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg, Cadila Healthcare said in a regulatory filing.
This combination medication is indicated for the treatment of Parkinson’s disease or Parkinson-like symptoms such as shakiness, stiffness, and difficulty moving and will be manufactured at the group's manufacturing facility at special economic zone (SEZ), Ahmedabad, it added.
The group now has 282 approvals and has so far filed over 386 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04, it said.
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