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Novo Nordisk launches new insulin device
NEW YORK — Novo Nordisk has launched a new insulin pen designed for children with diabetes.
The new NovoPen Echo is the first and only prefilled pen device in the United States that allows for half-unit dosing in combination with a memory function, the company said.
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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.