Thursday, December 18, 2008

Watson Receives FDA Approval for Generic Razadyne ER Capsules

Watson has received approval from the USFDA on its ANDA for galantamine hydrobromide ER capsules, eq. to 8 mg, 16 mg and 24 mg (galantamine base). Galantamine hydrobromide extended-release capsules are the generic equivalent to Ortho McNeil Janssen's Razadyne(R) ER, galantamine HBr extended-release capsules, which are indicated for the treatment of Alzheimer's disease.

Watson intends to launch the product immediately. Razadyne(R) ER had annual sales of approximately $112 million for the twelve months ending September 2008, according to IMS sales data.

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