Zydus Cadila Gets Tentative Nod From U.S. FDA To Market Parkinson’s Drug
Drug firm Zydus Cadila on Saturday said it has received tentative nod from the US health regulator to market Carbidopa and Levodopa extended-release capsules, used for the treatment of symptoms of Parkinson's disease, in the US market.
The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market the 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, Zydus Cadila said in a statement.
The drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad, it added. 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 group now has 295 approvals and has so far filed over 390 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.