Sun Pharmaceutical Industries Ltd, a Gujarat based major pharma company has received an approval from the USFDA to sell generic drug galantamine hydrobromide used in treating mild to moderate Alzheimer's disease. The approvals are for multiple strengths of extended- release capsules, 8 mg (base), 16 mg (base) and 24 mg (base).
"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.
"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.
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