United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 1997_register executive 2010-09-24 article Notices D09002ee1be014347 D09002ee1be0143dd United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing that orally administered drug products containing levothyroxine sodium are new drugs. There is new information showing significant stability and potency problems with orally administered levothyroxine sodium products. Also, these products fail to maintain potency through the expiration date, and tablets of the same dosage strength from the same manufacturer vary from lot to lot in the amount of active ingredient present. This lack of stability and consistent potency has the potential to cause serious health consequences to the public. Manufacturers who wish to continue to market orally administered levothyroxine sodium products must submit new drug applications (NDA's); manufacturers who contend that a particular drug product is not subject to the new drug requirements of the Federal Food, Drug, and Cosmetic Act (the act) should submit a citizen petition. FDA has determined that orally administered levothyroxine sodium products are medically necessary, and accordingly the agency is allowing current manufacturers 3 years to obtain approved NDA's. 62 FR 43535 https://www.govinfo.gov/app/details/FR-1997-08-14/97-21575 97-21575 fr14au97-83 4160-01-F Docket No. 97N-0314 https://www.govinfo.gov/app/details/FR-1997-08-14/97-21575 https://www.govinfo.gov/content/pkg/FR-1997-08-14/html/97-21575.htm https://www.govinfo.gov/content/pkg/FR-1997-08-14/pdf/97-21575.pdf 4 p. 43535 43538 62 FR 43535 Prescription Drug Products; Levothyroxine Sodium; Federal Register Vol. 62, Issue NOTICE 97-21575 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 97N-0314 4160-01-F 97-21575 Notice.

The Food and Drug Administration (FDA) is announcing that orally administered drug products containing levothyroxine sodium are new drugs. There is new information showing significant stability and potency problems with orally administered levothyroxine sodium products. Also, these products fail to maintain potency through the expiration date, and tablets of the same dosage strength from the same manufacturer vary from lot to lot in the amount of active ingredient present. This lack of stability and consistent potency has the potential to cause serious health consequences to the public. Manufacturers who wish to continue to market orally administered levothyroxine sodium products must submit new drug applications (NDA's); manufacturers who contend that a particular drug product is not subject to the new drug requirements of the Federal Food, Drug, and Cosmetic Act (the act) should submit a citizen petition. FDA has determined that orally administered levothyroxine sodium products are medically necessary, and accordingly the agency is allowing current manufacturers 3 years to obtain approved NDA's.

August 14, 1997. Christine F. Rogers, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. Vol. 62, no. 157 Office of the Federal Register, National Archives and Records Administration 1997-08-14 continuing daily deposited born digital 186 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1997-08-14 P0b002ee180a3d64b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr14au97 https://www.govinfo.gov/app/details/FR-1997-08-14 https://www.govinfo.gov/content/pkg/FR-1997-08-14/pdf/FR-1997-08-14.pdf fdlp 43453 43628 DGPO 2010-09-24 2023-05-06 FR-1997-08-14 machine generated eng FR FR-1997-08-14 62 157