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Sec 901 labeling change notification (cor-sec901lbl-01)

Description
Submit a rebuttal statement detailing the reasons why such a change is not ... requirements described in this letter apply to you, unless approval of your ...
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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationSilver Spring MD 20993NDA ##### SAFETY LABELING CHANGE NOTIFICATIONCOMPANY NAMESTREETCITY, STATE ZIP CODEAttention: COMPANY CONTACTDear COMPANY CONTACT:Please refer to your New Drug Applications (NDA) submitted under section 505(b) of theFederal Food, Drug, and Cosmetic Act (FDCA) for [TRADENAME].SAFETY LABELING CHANGESection 505(o)(4) of the FDCA authorizes FDA to require holders of approved drug andbiological product applications to make safety related label changes based upon new safetyinformation that becomes available after approval of the drug or biological product.Since [TRADENAME] was approved on [date of approval], we have become aware of a seriousrisk of disabling and potentially irreversible adverse reactions with the class of systemicfluoroquinolone antibacterial drug products, of which [TRADENAME] is a member. Theseserious adverse reactions have been observed to occur together, and include tendinitis, tendo...