Posted from: Wednesday, April 29, 2015 - 11:32 AM - Present

Generic Revatio Approved for Adult Pulmonary Arterial Hypertension

April 1, 2015 – The U.S. Food and Drug Administration (FDA) approved Aurobindo Pharma’s injectable sildenafil 10mg/12.5mL (0.8mg/mL), which is the generic to Pfizer’s Revatio solution for injection. Sildenafil is used to treat adult pulmonary arterial hypertension (PAH) patients who cannot swallow the oral tablet or liquid forms of the drug. The recommended dose is either 2.5mg or 10mg three times a day as a rapid intravenous (IV) injection.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.


Last Updated Monday, October 21, 2019 - 03:15 AM.