NIZORAL is indicated for the topical treatment of tinea corporis, tinea cruris, and tinea pedis caused by Trichophyton rubrum, T. NIZORAL (ketoconazole) topical cream, 2%, is the subject of NDA 019084, previously held by Johnson & Johnson Pharmaceutical Research and Development, LLC and initially approved on December 31, 1985. FDA may not approve an ANDA that does not refer to a listed drug. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 ( 21 CFR 314.161)). FDA publishes this list as part of the “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness ( 21 CFR 314.162).Ī person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. 355(j)(7)), which requires FDA to publish a list of all approved drugs. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. End Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Start Further Info FOR FURTHER INFORMATION CONTACT: This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. The Food and Drug Administration (FDA, Agency, or we) has determined that NIZORAL (ketoconazole) topical cream, 2%, was not withdrawn from sale for reasons of safety or effectiveness. Provide legal notice to the public or judicial notice to the courts.įood and Drug Administration, HHS. Rendition of the daily Federal Register on does not
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#Ketoconazole crema pdf
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