Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product
Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.
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Generic Advair's Labeling Variation Stems From Permissible Design Differences, US FDA Says
Patient instructions for use of Mylan’s fluticasone/salmeterol generic are noticeably different from GSK’s reference listed drug but fall within the ‘different manufacturers’ exception to the ‘same labeling’ requirement.
Teva Launches Generic EpiPen At Same Price As Mylan's Generic
Teva's epinephrine will be the first alternative to branded and authorized generics made by Mylan, but the wholesale acquisition cost of $300 for a two-pack won't be lower.