FDA holds off decision on psoriasis drug - - DermatologyTimes

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FDA holds off decision on psoriasis drug
Jan 6, 2009
By: Allison Tsai
Dermatology Times E-News

New York — The Food and Drug Administration (FDA) has held off making a decision on the psoriasis drug ustekinumab (Johnson & Johnson), until they receive certain risk-mitigation information, but will not require new studies, Reuters reports.

The FDA has issued a Complete Response letter for ustekinumab, which is sometimes issued when the agency needs more time to adequately review a drug, requesting additional information to ensure the drug’s benefits outweight the risks, according to a Johnson & Johnson press release.

The company says the letter also requests a medication guide and communication plan as part of the risk-mitigation information, which Johnson & Johnson says will be addressed next month, as the focus this month is on bringing the drug to market.
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Source: Dermatology Times E-News, 1/6/2009
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