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www.fdanews.com/articles/175765-fda-approves-tevas-generic-viagra

FDA Approves Teva’s Generic Viagra

March 16, 2016

Teva Pharmaceuticals scored FDA approval for its generic of the blockbuster erectile dysfunction drug Viagra, but it won’t be commercially available anytime soon.

Owing to a 2013 settlement with Viagra maker Pfizer, Teva won’t be able to launch the drug until December 2017 at the earliest, according to Teva spokeswoman Denise Bradley. The specific terms of the deal are confidential, but the December 2017 marketing date is mirrored in another confidential settlement Pfizer struck with Mylan in April 2015 regarding its efforts to develop generic Viagra.

FDA records show the agency approved the company’s ANDA for the drug under its chemical name — sildenafil citrate — last week at three dosage levels: 25 mg, 50 mg and 100 mg.