federal_register: 2020-15298
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-15298 | Vioform-Hydrocortisone Cream, Ointment, and Lotion Containing Iodochlorhydroxyquin and Hydrocortisone; Final Decision on Proposal To Withdraw Approval of New Drug Applications; Opportunity To Affirm Outstanding Appeal | Notice | The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), to withdraw approval of the new drug application (NDA) for Vioform-Hydrocortisone Cream, Ointment, and Lotion containing Iodochlorhydroxyquin and Hydrocortisone (Vioform), is the final decision of the Commissioner by operation of law. Several parties to the hearing, including the NDA holder and identical, related, or similar (IRS) product manufacturers, and a non-party participant timely filed exceptions to the ALJ's Initial Decision. FDA recently requested that the current owner of the NDA application, the IRS product manufacturers, and the non-party participant that had timely filed exceptions, or their successors-in-interest, affirm within a specific timeframe their interest in pursuing their appeals of the ALJ's Initial Decision. The NDA holder responded within the timeframe and withdrew its appeal. No other appellants that received actual notice of the Agency's request responded within the timeframe. Accordingly, FDA now deems any exceptions filed by appellants that received notice of the Agency's request to be withdrawn. FDA is, however, offering an opportunity to other IRS product manufacturers, or successors-in- interest, that submitted exceptions to the ALJ's Initial Decision and did not receive notice of FDA's request, to affirm their desire to pursue the appeal. The ALJ's Initial Decision is the final decision of the Commissioner by operation of law; however, if FDA receives a valid request to affirm the appeal, as described in this notice, we will withdraw this notice. | 2020-07-15 | 2020 | 7 | https://www.federalregister.gov/documents/2020/07/15/2020-15298/vioform-hydrocortisone-cream-ointment-and-lotion-containing-iodochlorhydroxyquin-and-hydrocortisone | https://www.govinfo.gov/content/pkg/FR-2020-07-15/pdf/2020-15298.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), to withdraw approval of the new drug application (NDA) for Vioform-Hydrocortisone Cream, Ointment, and Lotion containing... |