> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Turns Down Generic Tadalafil Oral Film
- URL: https://www.fdaweb.com/fda-turns-down-generic-tadalafil-oral-film/
- Published: 2018-11-19T12:00:00.000Z
- Updated: 2026-09-15T00:45:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142853

FDA has issued Aquestive Therapeutics a complete response letter (CRL) on its 505 (B)(2) NDA tadalafil oral film, a PDE5 inhibitor currently marketed (Eli Lilly’s Cialis) in tablet form for treating erectile dysfunction and benign prostatic hyperplasia, and for treating pulmonary arterial hypertension (Lilly’s Adcirca). The letter requested limited additional data from healthy volunteers, Aquestive says. The company has also notified the agency about its plans to engage an alternative supplier for the active pharmaceutical ingredient.

“The matters cited in the CRL are unique to the oral film formulation of tadalafil, and do not affect any other products that Aquestive develops, markets or manufactures,” the company says. “The comments provided in the CRL are manageable and we will work with the FDA to map out our path to resubmission and approval. We continue to see a pathway to tentative approval before the expiry of the patents for the reference product.”