Ensuring the Efficacy and Safety of Approved Medications

Author:

Mazer-Amirshahi Maryann,Cole Jon B.,Stolbach Andrew I.,Perrone Jeanmarie,Nelson Lewis S.

Publisher

Springer Science and Business Media LLC

Reference20 articles.

1. U.S. Food and Drug Administration. ANDA approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212955Orig1s000ltr.pdf. Accessed November 1, 2023.

2. U.S. Food and Drug Administration. neffy for the treatment of type I allergic reactions and anaphylaxis. https://www.fda.gov/media/167989/download. Accessed November 1, 2023.

3. Casale TB, Ellis AK, Nowak-Wegrzyn A, Kaliner M, Lowenthal R, Tanimoto S. Pharmacokinetics/pharmacodynamics of epinephrine after single and repeat administration of neffy, EpiPen, and manual intramuscular injection. J Allergy Clin Immunol. 2023 Aug 19:S0091-6749(23)01059-X. https://doi.org/10.1016/j.jaci.2023.08.007. Epub ahead of print.

4. U.S. Food and Drug Administration. Final Summary Minutes of the Pulmonary-Allergy Drugs Advisory Committee Meeting May 11, 2023. https://www.fda.gov/media/171359/download. Accessed November 1, 2023.

5. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/spl/data/d4bb0797-a4ed-4ed4-9904-604433eea4ff/d4bb0797-a4ed-4ed4-9904-604433eea4ff.xml. Accessed November 1, 2023.

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