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Vivus submits sNDA in support of a shorter efficacy window for its ED medicine Stendra
MOUNTAIN VIEW, Calif. — Vivus and Auxilium Pharmaceuticals on Tuesday announced that the Food and Drug Administration has accepted a supplemental application that proposes to revise the Stendra (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction."
The PDUFA date for the supplemental filing is Sept. 20, 2014.
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Actavis' Lo Loestrin Fe patent upheld
DUBLIN — Actavis last week confirmed that the U.S. District Court for the District of New Jersey found United States Patent No. 7,704,984 (the '984 Patent) to be valid and infringed by Lupin Pharmaceuticals and Amneal Pharmaceuticals Abbreviated New Drug Applications (ANDAs) for generic versions of Actavis' Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets).
Lo Loestrin Fe is a prescription birth control pill used for the prevention of pregnancy.