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# 3 NDAs Withdrawn Over No Annual Reports
- URL: https://www.fdaweb.com/3-ndas-withdrawn-over-no-annual-reports/
- Published: 2020-03-17T12:00:00.000Z
- Updated: 2026-09-14T16:07:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146344

*Federal Register* notice: FDA has withdrawn approval of three NDAs from multiple holders because they repeatedly failed to file required annual reports. The products withdrawn are Pan American Laboratories’ Maolate (chlorphenesin carbamate) tablet, 400mg, Iomed’s Iontocaine (epinephrine and lidocaine hydrochloride) topical solution, and Vyteris’ LidoSite Patch (lidocaine HCl and epinephrine topical iontophoretic patch) and LidoSite controller. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05498.pdf?ref=fdaweb.com).