MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for Tadalafil Oral Soluble Film (Tadalafil OSF) for the treatment of erectile dysfunction. The Tadalafil OSF NDA has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2017.
MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced the appointment of John T. Maxwell as its Chief Financial Officer, effective January 9, 2017. Mr. Maxwell will lead the Company’s financial and administrative operations.
MonoSol Rx, a specialty pharmaceutical company utilizing its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today filed a patent infringement case against BioDelivery Sciences International, Inc. (Nasdaq:BDSI) (“BDSI”) for infringement of U.S. Patent No. 8,765,167 (the ‘167 patent), which is entitled “Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions.” The ‘167 patent has a priority date as far back as 2001, as well as additional priority in 2005. The complaint was filed in the United States District Court for the District of New Jersey. The complaint asserts that the manufacture, marketing and sale of BDSI’s BELBUCA™ (buprenorphine) buccal film product infringes the ‘167 patent. Specifically, the complaint asserts infringement of claims 13, 33, 39, 45, 52, 66, 73, 83, 89, 95-98, 100-103, 105, 107, 108, 117 and 118 of the ’167 patent (Asserted Claims).
MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Diazepam Buccal Soluble Film (Diazepam BSF) for the treatment of Acute Repetitive Seizures (ARS). The Company plans to initiate a pivotal study of Diazepam BSF in adults in early 2017.
MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Tadalafil PharmFilm for the treatment of erectile dysfunction.
Lupin Pharmaceutical Inc., the US subsidiary of Lupin Ltd, has entered in a strategic licensing agreement with MonoSol Rx. The company would develop multiple pediatric products utilising MonoSol Rx's proprietary PharmFilm drug delivery technology.