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In Brief: J&J v. Penederm

This article was originally published in The Rose Sheet

Executive Summary

J&J v. Penederm: Johnson & Johnson alleges that Penederm's retinoic acid acne Avita gel infringes J&J's patent for its Retin-A gel acne treatment, in a suit filed in San Francisco federal court, Penederm said July 23. Penederm has not yet reviewed the allegations, but asserted that Avita does not infringe the patent. Penederm is currently awaiting FDA approval of its NDA for Avita gel and cream. In June, the company received two "non-approvability" letters from FDA requesting more efficacy data. Penederm submitted results from a three-month, 675-patient clinical study in July as an amendment to its NDA...
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