Zydus Lifesciences bags USFDA approval for Carbidopa and Levodopa Tablets to treat Parkinson's disease symptoms
The product will be manufactured at the group's formulation manufacturing facility in SEZ Ahmedabad, India.
Ahmedabad: Zydus Lifesciences Limited today announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg (USRLD: Sinemet Tablets, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg).
Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms (such as shakiness, stiffness, difficulty moving). This medicine is also used to treat Parkinson symptoms caused by carbon monoxide, carbon monoxide poisoning or manganese intoxication.
The product will be manufactured at the group’s formulation manufacturing facility in SEZ Ahmedabad, (India).
Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg had annual sales of USD 75 mn in the United States (IQVIA MAT Dec. 2022). The group now has 359 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.
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Medical Dialogues team had earlier reported that the company's U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. had received tentative approval from the USFDA to market Amantadine Extended-Release Capsules USP 68.5 mg and 137 mg (USRLD: Gocovri). The product is indicated for the treatment of dyskinesia (sudden uncontrolled movements) in patients with Parkinson's disease who are treated with levodopa therapy, with or without dopaminergic medicines.
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Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.
