FDA to Review New Film Formulation of Erectile Dysfunction Drug

The FDA has set a PDUFA target action date of September 18, 2017 to decide on the new Tadalafil NDA
The FDA has set a PDUFA target action date of September 18, 2017 to decide on the new Tadalafil NDA

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Tadalafil Oral Soluble Film (Tadalafil OSF; MonoSol Rx) for the treatment of erectile dysfunction (ED).

Tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor, is currently available in a tablet formulation for the treatment of ED and benign prostatic hyperplasia (BPH) under the brand name Cialis, and for treatment of pulmonary arterial hypertension under the brand name Adcirca. Tadalafil OSF is the first film alternative to the tablet formulation seeking for FDA approval. 

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MonoSol Rx is developing Tadalafil OSF utilizing its proprietary PharmFilm drug delivery technology. It will be offered in single pack doses and is expected to have several Orange Book listed patents upon approval.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2017 to make a decision on the NDA.

For more information visit Monosolrx.com.

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