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USFDA nod for Sun Pharma drug


Chennai, Oct. 23

Sun Pharmaceutical Industries Ltd has announced that the USFDA has granted final approval for the company’s abbreviated new drug application (ANDA) to market its generic version of Novartis Exelon capsules. These capsules come in four strengths: 1.5 mg (base), 3 mg (base), 4.5 mg (base) and 6 mg (base). These strengths have annual sales of $200 million in the US. The drug is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type and fo r the treatment of mild to moderate dementia associated with Parkinson’s disease. —

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