Treatment News : FDA Turns Down Prezista 800 mg Tablet - by Tim Horn

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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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  comments 1 - 2 (of 2 total)    

Jeton Ademaj, Harlem, NYC, 2012-06-01 00:40:12
to my knowledge there r some medications marketed up to 1200 milligrams per tablet or capsule. i cant imagine what they felt was wrong with the 800mg Prezista tablet. what, did it have spikes on it or something? i take Lovaza, KPAX tablets and 1 gram Valtrex tablets every day, there's no reason i cant do that with a single 800mg Prezista tablet. i wonder how the FDA will eventually react to the Prezista-quad pill currently being tested?...that thing is likely to top out around 1,200 mg...

Josh, Buffalo, NY, 2012-05-31 16:52:17
Any idea why the FDA decided not to approve this?

comments 1 - 2 (of 2 total)    


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