The Food and Drug Administration (FDA) approved generic version of Revatio – 20 mg (Sildenafil citrate) developed by Mylan laboratories. The manufacturer submitted Abbreviated New Drug Application (ANDA) for approval purpose. Mylan reported that the drug is generically equivalent to Pfizer’s Revatio and the generic version’s safety and efficacy is same as like Revatio.
Revatio is prescribed for the treatment of adult pulmonary arterial hypertension (PAH). Revatio can delay disease progress and to improve exercise ability in PAH patients.
At present, Mylan laboratories have 172 ANDAs that are yet to be approved by FDA. According to IMS Health, in United States market Revatio tablets gained nearly USD 338.7 million in 2011 – 2012. Mylan’s annual sale for a year is about USD 21.2 billions, IMS reported.
Unichem Laboratories Ltd.