Sun Pharmaceutical and Industries' subsidiary has received US FDA approval for an ANDA to market a generic version of Razadyne ER, galantamine hydrobromide extended release capsules.
These generic galantamine hydrobromide extended release capsules, 8 mg, 16 mg and 24 mg are indicated in the treatment of mild to moderate dementia of the Alzheimer's type. Razadyne ER, a registered trademark of Ortho-McNeil Janssen Pharmaceuticals, Inc., has annual sale of approximately $50 million in US.