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30/05/2012
JNJ Janssen unit: FDA letter rejects 800mg Prezista

The company doesn't expect additional clinical trials will be required to address the FDA's concerns.

A Johnson & Johnson (JNJ) unit said its supplemental new drug application for a once-daily oral treatment of Prezista to treat HIV received a preliminary rejection from the U.S. Food and Drug Administration.



Janssen Therapeutics, a division of Janssen Products LP, is developing a 800-milligram pill as an alternative to two, 400-milligram pills that are part of a current regimen to treat HIV.



The company submitted its application for the 800-milligram pill in January. Janssen said it is evaluating the complete response letter from the FDA and will respond as soon as possible. The company doesn't expect additional clinical trials will be required to address the FDA's concerns.



During the first quarter, JNJ reported global sales of Prezista totaled $324 million, or 5.3% of JNJ's global pharmaceutical sales of $6.13 billion.



JNJ shares closed Friday at $62.51 and were inactive premarket. Markets were closed Monday for the Memorial Day holiday.


By Tess Stynes