Aspargo Laboratories, Inc. is seeking FDA approval to market in the United States a patented oral spray formulation of sildenafil citrate, the active ingredient in VIAGRA®, to treat erectile dysfunction. Our current international focus is to obtain approval in Germany, the largest European market, as a prescription drug, and in the United Kingdom, where VIAGRA® tablets are available “over-the-counter” in the 25mg and 50mg dosage forms. Aspargo’s proprietary drug formulation is protected by granted U.S. and European patents that expire in 2036.
Aspargo has licensed the exclusive rights to commercialize Sildenafil Oral Spray in the United States and more than 30 countries throughout Europe, the United Kingdom, the Middle East, Asia, Canada, South America and Russia from Farmalíder, S.A. (Madrid, Spain), a leader in the Spanish OTC and ibuprofen market.
Aspargo is seeking FDA approval for Sildenafil Oral Spray under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which provides that new dosage forms and new routes of administration for a previously approved drug qualify for an expedited form of regulatory approval.
Sildenafil Oral Spray, distributed and marketed in Spain on behalf of Farmalider by Laboratorios Rubio under the trade name, “Bandol”, is prescribed by Spanish physicians to treat erectile dysfunction as an alternative to VIAGRA® and Cialis® tablets. The technology was approved by the Spanish regulatory authorities and commercially launched in Spain in late 2019.