Ivax Corporation has received final approval from the Federal Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for fluoxetine capsules in a 40 mg dosage and fluoxetine tablets in a 40 mg dosage. Fluoxetine is the generic equivalent of prozac, which is marketed by Eli Lilly and used in the treatment of depression, a release said.
Prozac and fluoxetine are currently sold in 10 mg, 20 mg and 40 mg capsule dosages and 10 mg and 20 mg tablet dosages. Ivax' fluoxetine 40 mg tablet is a new dosage strength.
According to IMS data, U S sales for prozac and its generic equivalent, fluoxetine in all current dosage sizes and forms is approximately $481 million for the past twelve months ending June 30, 2004 and $185 million for prozac and fluoxetine in 40 mg capsules for the past twelve months ending June 30, 2004. Fluoxetine 40 mg capsule and tablets will be launched by Ivax' wholly-owned subsidiary, Ivax Pharmaceuticals Inc.
Ivax continues its aggressive programme to increase the number of products in its generic portfolio, the release added.