In what has to be a rec0rd-setting year for approvable letters, GlaxoSmithKline for Requip® (ropinirole) XL™ for the treatment of Parkinson’s Disease has received an approvable letter from the FDA. According to the press release issued by GSK today, "this decision does not affect the immediate-release formulation of Requip® (ropinirole hydrochloride) Tablets, which is dosed three times a day and remains an important treatment for patients who suffer from idiopathic Parkinson’s disease. Requip XL is an investigational extended-release, once-daily formulation that uses SkyePharma PLC’s (LSE: SKP) patented GEOMATRIX™ technology. GSK is committed to working with the FDA to address any questions they have and evaluate the best way forward." No word on the reason for the approvable letter. It is worth noting that this version of Requip has been approved in several countries outside the U.S.
Remember, approvable letters are proprietary and the contents do not have to be revealed.