Ivax Corporation has received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for pravastatin sodium tablets in 10 mg, 20 mg and 40 mg dosage strengths. Upon final approval, this product will be sold through the company's wholly owned subsidiary, Ivax Pharmaceuticals Inc.
Pravastatin sodium is the generic equivalent of Pravachol, which is marketed by the Bristol-Myers Squibb Company and is prescribed for people with high cholesterol or heart disease. U.S. sales of Pravachol tablets, in 10 mg, 20 mg and 40 mg strengths, were $1.75 billion for the past twelve months, ending March 31, 2003.
Ivax currently has 39 ANDAs pending at the FDA. The company continues its aggressive filing schedule for new ANDA submissions.