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FDA holds off decision on psoriasis drug 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. | ![]() Stay Connected to Dermatology Times • Current Issue • Issue Archive • Subscribe to Enewsletter • Subscribe to Print Edition • Subscribe to Digital Edition • DT Radio • Events Calendar • Follow Us on Twitter
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