{"abstract":"The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for methylphenidate hydrochloride (HCl) extended-release (ER) tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/10/18/2016-25092.html","cfr_references":[],"citation":"81 FR 71741","comment_url":null,"comments_close_on":"2016-12-19","correction_of":null,"corrections":[],"dates":"Kremers Urban Pharmaceuticals Inc., may submit a request for a hearing by November 17, 2016. Submit all data, information, and analyses upon which the request for a hearing relies by December 19, 2016. Submit written or electronic comments by December 19, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-3120"],"dockets":[{"supporting_documents":[{"title":"Reference 121 Wigal, et al (1998). Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharm Bull, 34(1), 47-56. re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0489"},{"title":"Reference 116 Vitiello et al (2001). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0484"},{"title":"Reference 115 United States Pharmacopeia (USP), Convention (2017). Methylphenidate Hydrochloride Monograph re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0483"},{"title":"Reference 107 Stein et al (2003). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0475"},{"title":"Reference 101 Shram et al (2012). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0469"},{"title":"Reference 96 Schapperer et al (2015). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0464"},{"title":"Reference 81 Modi et al (2000). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0449"},{"title":"Reference 78 Micheal & Balamurali (2015). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0446"},{"title":"Reference 63 IMS Health National Sales Perspectives re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0431"},{"title":"Reference 57 Copyright Article (see abstract) re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0425"}],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2016-10-18","updated_at":"2023-02-28T19:29:19.788-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-3120-0001","allow_late_comments":null,"id":"FDA-2016-N-3120-0001","comment_end_date":"2016-12-20","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":525,"id":"FDA-2016-N-3120","title":"Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets"}],"document_number":"2016-25092","effective_on":null,"end_page":71745,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/10/18/2016-25092.xml","html_url":"https://www.federalregister.gov/documents/2016/10/18/2016-25092/kremers-urban-pharmaceuticals-inc-proposal-to-withdraw-approval-of-an-abbreviated-new-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-25092?publication_date=2016-10-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-10-18/2016-25092/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":2753,"last_updated":"2026-06-27 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-10-18/pdf/2016-25092.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-25092.pdf?1476708348","publication_date":"2016-10-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/10/18/2016-25092.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 121 Wigal, et al (1998). Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharm Bull, 34(1), 47-56. re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0489"},{"title":"Reference 116 Vitiello et al (2001). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0484"},{"title":"Reference 115 United States Pharmacopeia (USP), Convention (2017). Methylphenidate Hydrochloride Monograph re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0483"},{"title":"Reference 107 Stein et al (2003). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0475"},{"title":"Reference 101 Shram et al (2012). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0469"},{"title":"Reference 96 Schapperer et al (2015). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0464"},{"title":"Reference 81 Modi et al (2000). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0449"},{"title":"Reference 78 Micheal & Balamurali (2015). See Abstract Title re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0446"},{"title":"Reference 63 IMS Health National Sales Perspectives re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0431"},{"title":"Reference 57 Copyright Article (see abstract) re Request for Hearing from Kremers Urban Pharmaceuticals, Inc. (Alston & Bird)","document_id":"FDA-2016-N-3120-0425"}],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-3120","supporting_documents_count":525,"docket_id":"FDA-2016-N-3120","document_id":"FDA-2016-N-3120-0001","regulation_id_number":null,"title":"Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets","checked_regulationsdotgov_at":"2023-03-01T00:29:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":71741,"subtype":null,"title":"Kremers Urban Pharmaceuticals Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Opportunity for a Hearing","toc_doc":"Kremers Urban Pharmaceuticals Inc.; Extended-Release Methylphenidate Tablets; Withdrawal","toc_subject":"Abbreviated New Drug Applications:","topics":[],"type":"Notice","volume":81}