Switching patterns of immediate‐release forms of generic mixed amphetamine salts products among privately and publicly insured individuals aged 15–64 years in the United States, 2013

Switching patterns of immediate‐release forms of generic mixed amphetamine salts products among privately and publicly insured individuals aged 15–64 years in the United States, 2013–2019

Published:2023-07-04 Issue:10 Volume:32 Page:1178-1183
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiology and Drug

Author:

Perez‐Vilar Silvia¹^ORCID,Kempner Maria E.²,Dutcher Sarah K.¹^ORCID,Menzin Talia J.²^ORCID,Woods Corinne¹^ORCID,Leishear Kira¹^ORCID,Osterhout James³,Adimadhyam Sruthi²^ORCID,Adereti Modupeola¹^ORCID,Carruth Amanda²,Hansbury Aaron²,Sandhu Sukhminder K.¹,Lyons Jennifer G.²^ORCID

Affiliation:

1. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA

2. Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Boston Massachusetts USA

3. Office of Generic Drugs, Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA

Abstract

AbstractPurposeImmediate‐release forms of generic mixed amphetamine salts (MAS) have been the subject of passive surveillance reports signaling lack of effectiveness. We examined switching patterns that might suggest whether long‐term users of specific MAS are more likely to switch away or switch back after use of the MAS of interest in the FDA's Sentinel Distributed Database.MethodsWe required at least 60‐day continuous supply of selected MAS grouped by Abbreviated New Drug Application (ANDA) to describe patterns of switching away from and to generics approved under the ANDAs of interest among individuals ages 15–64 years with attention deficit hyperactivity disorder or narcolepsy during 2013–2019.ResultsWe observed the greatest number of treatment episodes for ANDA 040422 (n = 525 771), followed by ANDA 202424 (n = 181 693), ANDA 040439 (n = 62 363), ANDA 040440 (n = 21 143), and ANDA 040480 (n = 8792). Of those with switches away from their original ANDA, episodes initiated on generic products under ANDA 040422 (48.6%) and ANDA 202424 (43.0%) were most likely to switch back, while those initiated on generic product under ANDA 040480 were least likely (24.1%). Of those episodes with switches to a generic under an ANDA of interest, about one‐third (range 27.1% to 37.0%) switched back to the same product. These switches back had a median time to switch of about 30 days.ConclusionsThese descriptive analyses, although subject to limitations, did not suggest increased switching away or switching back after use of the generics of interest. Continued post‐marketing surveillance is warranted.

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5661

Reference10 articles.

1. US Food and Drug Administration.Adderall Teva Branded Pharmaceutical Products R&D Inc. US labeling.2022.

2. US Food and Drug Administration.Referencing approved drug products in ANDA submissions guidance for industry. Accessed April 18.2020https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/referencing‐approved‐drug‐products‐anda‐submissions‐guidance‐industry

3. US Food and Drug Administration.Abbreviated new drug application (ANDA): 040422. DEXTROAMP SACCHARATE AMP ASPARTATE DEXTROAMP SULFATE AND AMP SULFATE. Original approval. Accessed May 27.2002https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040422.PDF

4. US Food and Drug Administration.MedWatch: the FDA safety information and adverse event reporting program. Accessed June 17.2022https://www.fda.gov/safety/medwatch‐fda‐safety‐information‐and‐adverse‐event‐reporting‐program

5. The FDA Sentinel Initiative — An Evolving National Resource