federal_register: 2014-23961
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-23961 | Determination That LUPRON DEPOT (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | The Food and Drug Administration (FDA) has determined that LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 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 (leuprolide acetate for depot suspension), Injectable 3.75 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 (leuprolide acetate for depot suspension), Injectable 3.75 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. | 2014-10-08 | 2014 | 10 | https://www.federalregister.gov/documents/2014/10/08/2014-23961/determination-that-lupron-depot-leuprolide-acetate-for-depot-suspension-injectable-375 | https://www.govinfo.gov/content/pkg/FR-2014-10-08/pdf/2014-23961.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) has determined that LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow... |