An Austin company is preparing to launch the first 60-milligram generic version of the antidepressant Prozac to be sold in the United States.
Edgemont Pharmaceuticals LLC received approval in October from the U.S. Food and Drug Administration to market the 60 mg version of fluoxetine. Last year, more than 24.4 million prescriptions were written for fluoxetine in the United States, up 7 percent from 2009, according to SDI’s Vector One. Fluoxetine ranked No. 25 on the list of the top generic drugs prescribed in 2010.
U.S. spending on antidepressants – including fluoxetine – totaled $11.6 billion in 2010, with 253.6 million prescriptions written, according to the IMS Institute for Healthcare Informatics.
Edgemont’s product is the only form of fluoxetine available in the United States in one 60 mg pill. The pill comes with a “scoring” feature that lets it be split into two 30 mg doses. Until now, patients requiring a 30 mg or 60 mg dose of fluoxetine had to take three 10 mg pills or three 20 mg pills to reach the targeted dose.
In October, Douglas Saltel, president and CEO of Edgemont, said that by reducing the dosage of fluoxetine from three pills to one, he hopes more patients will be able to stick to their treatment regimens. “This is an especially important goal for the higher-milligram-dose patients that may be having trouble controlling their symptoms of depression,” Saltel said.
Aside from major depression, fluoxetine is used to treat obsessive-compulsive disorder, panic disorder and bulimia.
Finland-based Orion Corp. manufactures the 60 mg generic version of fluoxetine for Edgemont.
Edgemont has hired HCB Health, a health care communications agency in Austin, to handle advertising and other promotional activities for the new fluoxetine drug.
Prozac was introduced by Eli Lilly and Co. in 1986. Eli Lilly’s Prozac patent expired in 2001, opening the door to generic versions.
Comments