Complete Response Letters

United Therapeutics Corporation: treprostinil

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, Oct 15, 2021

FDA-2021-P-0714) regarding the approvability of NDA 214324 for Tyvaso DPI.

Complete Response Letter · Oct 15, 2021 · p. 4Open the letter at p. 4 ↗CRL_NDA214324_20211015:p2:s22

Implantable System for Remodulin (ISR) user interface supports safe and effective use for the intended users, uses and use environments.

Complete Response Letter · Jun 2, 2017 · p. 2Open the letter at p. 2 ↗CRL_NDA208276_20170602:p1:s23

2016 FDA information request regarding the low concentration of m-Cresol in the drug product following delivery by Medtronic PAH1 System.

Complete Response Letter · Oct 7, 2016 · p. 7Open the letter at p. 7 ↗CRL_NDA208276_20161007:p1:s27

However, the application does not contain data demonstrating that the catheter is a "closed system" from the standpoint of microbial ingress.

Complete Response Letter · Oct 7, 2016 · p. 7Open the letter at p. 7 ↗CRL_NDA208276_20161007:p1:s29

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