Sun Pharmaceutical Industries Ltd on 3 February 2011 declared that it received an approval from the US health regulator to sell generic drug galantamine hydrobromide. Galantamine hydrobromide is used in treating mild to moderate Alzheimer's disease in the American market. The US Food and Drug Administration granted 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 approvals are for multiple strengths of extended- release capsules, 8 mg (base), 16 mg (base) and 24 mg (base).
Razadyne ER is a registered trademark of Ortho-McNeil Janssen Pharmaceuticals and records an annual sale of around USD 50 million in the US.
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