Shares of Iterum Therapeutics plunged on July 26 after the U.S. Food and Drug Administration rejected the company’s New Drug Application for oral sulopenem as a potential treatment for uncomplicated urinary tract infections (uUTI) in patients with a quinolone non-susceptible pathogen.
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.
The U.S. Food and Drug Administration approved Eli Lilly and Co.’s Reyvow, representing the first new class of acute migraine treatment approved by the regulatory agency in more than two decades.
The U.S. Food and Drug Administration approved Fera’s New Drug Application for Avaclyr (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis.
The U.S. FDA approved the New Drug Application of Xelpros 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.