Dec 17 2008
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.