The safety and adverse event profile observed in this study was comparable to the known safety profile of Revatio
in prior studies in pediatric and adult patients with pulmonary arterial hypertension taking Revatio
Using the HDAP drug classifications in conjunction with substitute medications identified by the Patented Medicine Price Review Board, this study constructs prescription costs per prescribed day for 266 branded medications and generic equivalents across 27 different drug categories (eg, the erectile dysfunction drug Viagra, Cialis, Revatio
, Adcirca, Levitra, Staxyn, and generic Sildenafil).
PDE5 inhibitors are the treatment of erectile dysfunction [sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis), udenafil (Zydena)] and idiopathic pulmonary hypertension [sildenafil (Revatio
)], although several other potentials have also been identified, such as memory improvement, anticancer therapy and treatment of heart diseases (Glossmann et al., 1999).
The FDA's division of bioequivalence has determined Aurobindo's product to be bioequivalent and therapeutically equivalent to the referenced listed drug (RLD), which is Revatio
tablets (Pfizer Inc.).
YTD Earnings: $19.4 billion (earnings were $8.3 billion YTD13) Comments: Specialty Care revenues were $3.3 billion in the quarter, down 2%, primarily due to the shift in the reporting of Geodon and Revatio
revenues in the U.S.
Treatment options for pulmonary hypertension associated with scleroderma include the endothelin receptor antagonist bosentan (Tracleer); the phosphodiesterase inhibitors sildenafil (Revatio
), vardenafil (Levitra) or tadalafil (Adcicra); and various prostacyclin analogs, such as epoprostenol (Flolan), treprostinil (Remodulin) and iloprost (Ventavis).
Sildenafil citrate (active ingredient of Viagra and Revatio
) is a competitive and selective inhibitor of cyclic guanosine monophosphate (cGMP) phosphodiesterase type 5 (PDE5), and thus inhibits the degradation of cGMP without affecting cyclic AMP (cAMP) .
M2 EQUITYBITES-November 14, 2012-Mylan Inc unveils generic Revatio
Tablets (20mg) for treating pulmonary arterial hypertension in adults(C)2012 M2 COMMUNICATIONS http://www.m2.com
M2 PHARMA-November 14, 2012-Mylan Inc unveils generic Revatio
Tablets (20mg) for treating pulmonary arterial hypertension in adults(C)2012 M2 COMMUNICATIONS
The Food and Drug Administration is warning physicians not to use off-label Revatio
(sildenafil) to treat pulmonary arterial hypertension in children younger than 18 years.
An emerging option for the treatment of pediatric pulmonary hypertension is phosphodiesterase 5 inhibitors (PDE), especially sildenafil in the form of Revatio
, oral 20mg three times per day.
The FDA also approved three more drugs, Remodulin, Ventavis, and Revatio
in 2002, 2004 and 2005 respectively for the treatment of PAH.