Eli Lilly & Co. has received approval from the Mexican regulatory authorities for Cialis, an oral PDE5 inhibitor for the treatment of erectile dysfunction.
The drug, which was developed through a collaboration between Eli Lilly and Icos Corporation, is now available in pharmacies by prescription in Mexico.
With the product introduction in Mexico, Cialis is now available in more than 40 countries on six continents. In the US, Cialis is currently under review by the FDA with Lilly Icos expecting a regulatory decision late in 2003.
"Mexico is one of the top ten world markets for ED therapies. There are an estimated five million Mexican men who suffer from erectile dysfunction and, with the regulatory approval of Cialis, they now have a new treatment option," said Edmundo Jimenez, director of marketing at Eli Lilly, Mexico.
Friday, September 18, 2009
Wednesday, September 16, 2009
Stress Urinary Incontinence Update
FDA requests further data before approval of Eli Lilly's duloxetine
Eli Lilly and Company [LLY] has received an approvable letter from the FDA's division of reproductive and urologic drug products for duloxetine for the treatment of stress urinary incontinence. Final FDA approval is contingent upon successful completion of additional acute preclinical and clinical pharmacology studies.
Satisfactory resolution of manufacturing issues at Lilly's Indianapolis manufacturing facilities, including the completion of a pre-approval site inspection; and completion of label negotiations will be factors in the FDA approval process. Lilly plans to conduct discussions with the FDA concerning the company's plans to provide the information the agency has requested. The results of these discussions will allow the company to provide a better estimate of the potential US approval date. Currently, pending more precise information, Lilly anticipates a US approval of duloxetine for SUI in late 2004 or the first half of 2005.
Duloxetine for depression, known as Cymbalta, is also currently under review by the FDA's division of neuropharmacologic drug products. Lilly received an approvable letter from the FDA for Cymbalta in September 2002.
"We are committed to bringing our innovative late stage products as quickly as possible to the patients who need them, to that end, we will work rapidly to provide the additional data requested by the agency and to resolve our outstanding manufacturing issues." said Sidney Taurel, chairman, president and CEO, Eli Lilly and Company, in a media release.
In November 2002, Lilly and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize Duloxetine hydrochloride.
Duloxetine is currently being developed for the treatment of stress urinary incontinence (SUI) and depression. This partnership covers most countries worldwide with few exceptions. In the US, the collaboration is for SUI only.
Eli Lilly and Company [LLY] has received an approvable letter from the FDA's division of reproductive and urologic drug products for duloxetine for the treatment of stress urinary incontinence. Final FDA approval is contingent upon successful completion of additional acute preclinical and clinical pharmacology studies.
Satisfactory resolution of manufacturing issues at Lilly's Indianapolis manufacturing facilities, including the completion of a pre-approval site inspection; and completion of label negotiations will be factors in the FDA approval process. Lilly plans to conduct discussions with the FDA concerning the company's plans to provide the information the agency has requested. The results of these discussions will allow the company to provide a better estimate of the potential US approval date. Currently, pending more precise information, Lilly anticipates a US approval of duloxetine for SUI in late 2004 or the first half of 2005.
Duloxetine for depression, known as Cymbalta, is also currently under review by the FDA's division of neuropharmacologic drug products. Lilly received an approvable letter from the FDA for Cymbalta in September 2002.
"We are committed to bringing our innovative late stage products as quickly as possible to the patients who need them, to that end, we will work rapidly to provide the additional data requested by the agency and to resolve our outstanding manufacturing issues." said Sidney Taurel, chairman, president and CEO, Eli Lilly and Company, in a media release.
In November 2002, Lilly and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize Duloxetine hydrochloride.
Duloxetine is currently being developed for the treatment of stress urinary incontinence (SUI) and depression. This partnership covers most countries worldwide with few exceptions. In the US, the collaboration is for SUI only.
Subscribe to:
Posts (Atom)