TITUSVILLE, N.J., May 29, 2012 /PRNewswire/ -- 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.
Janssen is developing the 800mg tablet dosage strength to allow patients taking PREZISTA once daily to reduce the number of PREZISTA tablets by half, taking one 800mg tablet instead of two 400mg tablets once a day with ritonavir 100mg and other antiretroviral medications.
The sNDA for the 800mg tablet strength was submitted in January 2012. Janssen is evaluating the FDA's letter and will respond to the agency as quickly as possible. The company does not expect additional clinical trials will be required to address the FDA's feedback in the Complete Response letter. Janssen continues to believe the 800mg PREZISTA tablet is an important option and is committed to making it available to patients.
PREZISTA is a protease inhibitor and was first approved in the United States in 2006. It is marketed in the U.S. by Janssen Therapeutics.
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors. PREZISTA® is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food.
PREZISTA® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA®.
Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you.
Important Safety Information
What is the most important information I should know about PREZISTA®?
Who should not take PREZISTA®?
This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
What should I tell my doctor before I take PREZISTA®?
What are the possible side effects of PREZISTA®?
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please refer to the ritonavir (Norvir®) Product Information (PI and PPI) for additional information on precautionary measures.
Please see full Prescribing Information for more details, available at: http://prezista.com/sites/default/files/pdf/us_package_insert.pdf
About Janssen Therapeutics
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in HIV and other infectious diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Headquartered in Titusville, New Jersey, Janssen Therapeutics, Division of Janssen Products, LP, is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Visit www.JanssenTherapeutics.com for more information and follow us on Twitter at @JanssenUS.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Products, LP and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; manufacturing difficulties or delays; and product efficacy or safety concerns. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Products, LP nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
Pamela Van Houten
Phone: +1-732 524-6491
|SOURCE Janssen Therapeutics|
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