Complete Response Letters

Defender Pharmaceuticals, Inc: scopolamine

What FDA's Complete Response Letters to the company say, in the letters' own words.

EphemerisX Research · Sep 30, 2026 · Sources: FDA, SEC

Complete Response Letter, Jan 25, 2024

1. The submitted data are insufficient to support the demonstration of efficacy for scopolamine nasal gel for the prevention of nausea induced by motion.

Complete Response Letter · Jan 25, 2024 · p. 6Open the letter at p. 6 ↗CRL_NDA214315_20240125:p3:s0

Provide additional clinical data to support the demonstration of safety and effectiveness of scopolamine nasal gel for the "prevention of nausea" portion of the proposed indication (i.e., the prevention of nausea induced by motion).

Complete Response Letter · Jan 25, 2024 · p. 6Open the letter at p. 6 ↗CRL_NDA214315_20240125:p3:s3

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Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.