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Sun Pharmaceutical Industries Ltd has received an approval from the US health regulator to sell generic drug galantamine hydrobromide used in treating mild to moderate Alzheimer’s disease in the American market.
“The US Food and Drug Administration has granted its (Sun’s) subsidiary an approval for an abbreviated new drug application (ANDA) to market a generic version of Razadyne ER, galantamine hydrobromide extended release capsules,” the company said in a statement.
Razadyne ER is a registered trademark of Ortho-McNeil Janssen Pharmaceuticals and has an annual sale of around $50 million in the US, it said.
The approvals are for multiple strengths of extended-release capsules, 8 mg (base), 16 mg (base) and 24 mg (base), the company added.
The company shares ended the session today at Rs 438.50 per share on the Bombay Stock Exchange, up 0.54 per cent from the previous close.
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