Not Approvable Letter on RISPERDAL(R) (risperidone) in the Treatment of Autism

Main Category: Autism
Article Date: 22 May 2005 - 7:00 PDT

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Johnson & Johnson Pharmaceutical Research & Development, LLC, announced that it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) regarding a Supplemental New Drug Application (sNDA) for RISPERDAL(R) (risperidone) in the treatment of autism.

Recognizing the unmet need in this area is great, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is evaluating the FDA's letter and will determine appropriate next steps.

A global leader in pharmaceutical research and development, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is a member of the Johnson & Johnson Family of Companies and is committed to bringing to market high-value, cost effective products that treat disease and significantly improve the health and lifestyles of people worldwide. Research areas include psychiatry, gastroenterology, oncology, anti-infective, central nervous system, diabetes, hematology, immunology/inflammation, women's health and wound healing. For more information, visit http://www.jnjpharmarnd.com.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. 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 Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99(b) of the Company's Annual Report on Form 10-K for the fiscal year ended January 2, 2005. Copies of this Form 10-K are available online at http://www.sec.gov or on request from the Company. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.

http://www.jnj.com/news

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