Sun Pharma gets US FDA nod to sell generic Alzheimer's disease drug

NEW DELHI: Sun Pharmaceutical Industries Ltd today said it 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 USD 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.

Sun Pharmaceutical Industries scrips were trading at Rs 437.85 per share during the afternoon trade at the Bombay Stock Exchange, up 0.39 per cent from the previous close.