FDA Sends Approvable Letter For Thelin
The FDA sent an "approvable letter" to Encysive Pharmaceuticals Inc.'s for their new drug Thelin. Providing Thelin can meet certain conditions, it can be approved for treating a rare, often-fatal lung condition.
Thelin has the same active ingrediants as Pfizer's Viagra, sildenafil citrate.
The FDA did not disclose the conditions, however, the Houston-based Encysive Pharmaceuticals is seeking permission to sell Thelin for treating pulmonary arterial hypertension (PAH), which causes severe shortness of breath and often kills.
The failure to win full approval for Thelin will likely be viewed as positive for Swiss biotechnology company Actelion, which relies heavily on its PAH treatment Tracleer to sustain growth. The delay with Thelin will provide a boost to forecast sales for Actelion's product Tracleer.
Tracleer once had the PAH market pretty much to itself, it is now facing increased competition from Pfizer Inc.'s Revatio, containing the same active ingredient as Viagra. Thelin would be another direct competitor for treating the rare condition that often leads to the need for a heart and lung transplant.
A fourth drug for PAH called ambrisentan is being developed by Myogen Inc..
Follow the daily health and medical news updates, including the debate over allowing cheaper generic forms of medicines to compete on a free market.
Thelin has the same active ingrediants as Pfizer's Viagra, sildenafil citrate.
The FDA did not disclose the conditions, however, the Houston-based Encysive Pharmaceuticals is seeking permission to sell Thelin for treating pulmonary arterial hypertension (PAH), which causes severe shortness of breath and often kills.
The failure to win full approval for Thelin will likely be viewed as positive for Swiss biotechnology company Actelion, which relies heavily on its PAH treatment Tracleer to sustain growth. The delay with Thelin will provide a boost to forecast sales for Actelion's product Tracleer.
Tracleer once had the PAH market pretty much to itself, it is now facing increased competition from Pfizer Inc.'s Revatio, containing the same active ingredient as Viagra. Thelin would be another direct competitor for treating the rare condition that often leads to the need for a heart and lung transplant.
A fourth drug for PAH called ambrisentan is being developed by Myogen Inc..
Follow the daily health and medical news updates, including the debate over allowing cheaper generic forms of medicines to compete on a free market.
posted by Clive Wallace at 5:11 AM
<< Home