federal_register: 06-9713

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
06-9713 Drug Products Containing Quinine; Enforcement Action Dates Notice The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products containing quinine (including quinine sulfate and any other salt of quinine) and persons who cause the manufacture of such products or their shipment in interstate commerce. Drug products containing quinine, quinine sulfate, and any other salt of quinine are new drugs that require approved applications. One firm has an approved application to market a drug product containing quinine sulfate to treat malaria; this product has been designated an orphan drug product. Other manufacturers who wish to market a drug product containing quinine, quinine sulfate, or any other salt of quinine must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA); consideration of any such applications will be subject to the rights of the current NDA holder under the Orphan Drug Act. 2006-12-15 2006 12 https://www.federalregister.gov/documents/2006/12/15/06-9713/drug-products-containing-quinine-enforcement-action-dates https://www.govinfo.gov/content/pkg/FR-2006-12-15/pdf/06-9713.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products containing quinine (including quinine sulfate and any other salt of quinine) and persons who cause the manufacture of such...

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