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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Injectors used for emergency administration of drugs such as epinephrine should be demonstrate a ‘remote probability’ of failure equating to no more than one in every 100,000 injection attempts, agency says in a new draft guidance that may have relevance for other types of emergency-use drug delivery devices.
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'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.