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May 30, 2012

FDA Turns Down Prezista 800 mg Tablet

by Tim Horn

The U.S. Food and Drug Administration has not approved Janssen Therapeutics’ application to market an 800 milligram (mg) tablet version of its protease inhibitor Prezista (darunavir), The Associated Press reports

Janssen plans to respond to the FDA’s letter regarding the 800 mg Prezista application as quickly as possible, in an effort to address lingering approval issues.

Though Pam Van Houten, a Janssen spokesperson, declined to discuss the specific issues in the FDA letter when contacted by AIDSmeds, the company does not expect additional clinical trials will be necessary to address the FDA’s feedback.

For people living with HIV not harboring resistance mutations to Prezista, the protease inhibitor can still be taken once daily at a dose of 800 mg—in the form of two 400 mg tablets—combined with 100 mg Norvir (ritonavir).

Janssen is developing the 800 mg tablet to allow people taking once-daily Prezista to reduce their pill volume.

“I do want to make sure it is clear that this letter is only for the 800 mg tablet,” Van Houten said. “It doesn’t impact the 800 mg indication. Patients can continue taking two 400 mg tablets for the once-daily indication.”

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