Aspargo Laboratories, Inc. Announces Successful Completion of Pre-IND Meeting with FDA on Sildenafil Oral Spray for the Treatment of Erectile Dysfunction
The FDA was supportive of a single dose bioequivalent study comparing Aspargos Sildenafil Oral Spray, an oral liquid suspension formulation of sildenafil citrate, with Viagra tablets and deemed the 505(b)(2) regulatory pathway appropriate for the program.
- The FDA was supportive of a single dose bioequivalent study comparing Aspargos Sildenafil Oral Spray, an oral liquid suspension formulation of sildenafil citrate, with Viagra tablets and deemed the 505(b)(2) regulatory pathway appropriate for the program.
- We look forward to advancing Sildenafil Oral Spray in the U.S. market to provide men who suffer from erectile dysfunction a differentiated dosing formulationthat provides convenient administration, flexible dosing and access for ED patients who have difficulty swallowing oral tablets.
- Aspargo is the exclusive U.S. licensee of the U.S. patent rights covering Sildenafil Oral Spray from Farmalider, S.A. of Madrid, Spain ( www.farmalider.com ).
- Except as required by law, Aspargo disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.