Teva Pharmaceutical (NYSE:TEVA) said last week that it hopes to win U.S. approval for its version of Mylan‘s (NSDQ:MYL) EpiPen by late 2017 or early 2018. Mylan’s EpiPen holds an estimated 94% market share in the U.S.; an alternate device from Teva could threaten the product’s dominance. Teva’s application for its epinephrine injector has been […]
FDA request delays timeline for Sanofi’s iGlarLixi drug-device combo for diabetes
By Sarah Faulkner The FDA’s request for more data on the iGlarLixi drug-device combination for treating Type II diabetes pushed the timeline for a decision back 3 months, Sanofi (NYSE:SNY) and Zealand Pharma (CPH:ZEAL) said last week. Sanofi said August 19 that it submitted a new data package for iGlarLixi, an injection pen designed to […]
FDA draft guidance on 510(k)s omits combination devices
Combination medical devices which bring together device components and drugs or biological products into a single unit are missing from new draft guidance from the FDA. The guidance, released last week, covered recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market, replacing guidance that was 19 years […]
Intersect ENT files with FDA for drug-delivering sinus implant
Intersect ENT (NSDQ:XENT) said today it submitted a supplemental premarket approval submission to the FDA seeking approval for a new Nova steroid releasing implant for treating patients with chronic sinus disease. The new Nova device is designed with a lower profile to allow for placement in smaller sinus openings, and will expand the usable patient population for […]
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