Drug firm Indoco Remedies said it has received approval from the US health regulator for Rasagiline tablets, used for treatment of Parkinson’s disease.
The company has received final nod for its abbreviated new drug application (ANDA) for Rasagiline tablets in the strengths of 0.5 mg and 1 mg from the United States Food and Drug Administration (US FDA), Indoco Remedies said in a regulatory filing.
Quoting IMS 2018 data, Indoco Remedies said the market size of this product in the US is USD 105 million. “This is the first ANDA approval for Indoco after receipt of warning letter in March 2017 for Goa plant II and III. The company has 32 ANDAs pending for approval for different dosage forms from this site,” Indoco Remedies Managing Director Aditi Kare Panandikar said.