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2014-10-07
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Determination That LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial and 7.5 Milligrams/Vial; and LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 7.5 Milligrams/Vial and 7.5 Milligrams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) has determined that LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 milligrams (mg)/vial and 7.5 mg/vial; and LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for leuprolide acetate for depot suspension, injectable 3.75 mg/vial and 7.5 mg/vial; and injectable 7.5 mg/vial and 7.5 mg/vial, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for leuprolide acetate for depot suspension, future applicants are advised that they may not be able to obtain LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/ vial and 7.5 mg/vial, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and the same therapeutic effect.
79 FR 49327
https://www.govinfo.gov/app/details/FR-2014-08-20/2014-19713
2014-19713
fr20au14-75
4164-01-P
Docket No. FDA-2013-P-1510
https://www.govinfo.gov/app/details/FR-2014-08-20/2014-19713
https://www.govinfo.gov/content/pkg/FR-2014-08-20/html/2014-19713.htm
https://www.govinfo.gov/content/pkg/FR-2014-08-20/pdf/2014-19713.pdf
2 p.
49327
49328
79 FR 49327
Determination That LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial and 7.5 Milligrams/Vial; and LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 7.5 Milligrams/Vial and 7.5 Milligrams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Federal Register Vol. 79, Issue
NOTICE
2014-19713
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-P-1510
4164-01-P
2014-19713
Notice.
The Food and Drug Administration (FDA) has determined that LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 milligrams (mg)/vial and 7.5 mg/vial; and LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for leuprolide acetate for depot suspension, injectable 3.75 mg/vial and 7.5 mg/vial; and injectable 7.5 mg/vial and 7.5 mg/vial, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for leuprolide acetate for depot suspension, future applicants are advised that they may not be able to obtain LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/ vial and 7.5 mg/vial, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and the same therapeutic effect.
Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-402-0979.
Determinations that Products were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:
LUPRON DEPOTPED (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial and 7.5 Milligrams/Vial, etc.
,
Federal Register
Vol. 79, no. 161
Office of the Federal Register, National Archives and Records Administration
2014-08-20
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210 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2014-08-20
P0b002ee189da3713
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0042-1219
0364-1406
769-004-00000-9
000582072
f:fr20au14
https://www.govinfo.gov/app/details/FR-2014-08-20
https://www.govinfo.gov/content/pkg/FR-2014-08-20/pdf/FR-2014-08-20.pdf
https://www.govinfo.gov/content/pkg/FR-2014-08-20/xml/FR-2014-08-20.xml
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2014-10-07
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