Zydus gets FDA's tentative nod for generic Rytary

Zydus Cadila has received the Food and Drug Administration's tentative approval for carbidopa and levodopa extended-release capsules in dosage strengths of 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg.

The product is the generic of Impax Pharmaceuticals’ Rytary.

The combination medication is indicated for the treatment of Parkinson’s disease or Parkinson like symptoms (such as shakiness, stiffness, and difficulty moving).

Zydus Cadila’s product will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad.