Watson Pharmaceuticals receives FDA approval for generic Razadyne ER capsules

Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for galantamine hydrobromide extended-release 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.