FDA delays once-a-day Prezista approval; finds counterfeit of Teva's Adderall

30 May 2012

US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Therapeutics division has received a complete response letter for the US Food and Drug Administration for a Supplemental New Drug Application (sNDA) for an 800mg tablet formulation of Prezista (darunavir).

The FDA approved the 400mg version of Prezista in 2006 for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations.

Janssen is developing the 800mg tablet dosage strength to allow patients taking Prezista once daily to reduce the number of tablets by half, taking one 800mg tablet instead of two 400mg tablets once a day with ritonavir 100mg and other antiretroviral medications.

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