An application for a higher dosage of an FDA-approved HIV drug from Janssen Pharmaceuticals has been turned down by the U.S. Food and Drug Administration, according to a company statement.
The complete response letter was for an 800 milligram dose of Prezista, a protease inhibitor. The Titusville, New Jersey company, the Pharmaceutical Division of Johnson & Johnson (NYSE:JNJ), currently has a 400 milligram dose on the market that was approved in 2006 to be taken twice daily. It submitted the application for a higher dosage in January.
A complete response letter is issued when the FDA decides it can’t approve a drug application in its current form for various reasons. Once companies have addressed issues raised in the letters they can resubmit their drugs for approval.
Patients with HIV are frequently prescribed several medications that they have to take throughout the day, which can make it difficult to remember to take them all. But with an immunodeficiency disease, forgetting to take a dose can threaten a patient’s health.
Last year, Prezista had sales of $1.2 billion in 2011, a 41 percent increase over the previous year. In the first quarter of 2012, it had sales of $324 million, a 22 percent increase over the same period last year.
Last year, Janssen recalled 2,000 packages of Prezista because of a reportedly musty odor emanating from containers.