FDA Issues Complete Response Letter for 800mg PREZISTA
Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter for a Supplemental New Drug Application (sNDA) for an 800mg tablet of PREZISTA® (darunavir).
PREZISTA is approved for once-daily oral administration of 800mg -- two 400mg tablets -- for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations. PREZISTA is always taken with and at the same time as ritonavir with food and in combination with other HIV medicines.
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