Tag: Abbreviated New Drug Application (ANDA)

Vibex Auto-Injector from Teva partner Antares

Is Teva Finally Preparing to Launch Their EpiPen Generic After Lengthy...

Dave Bloom -
Though entirely speculation, Indications from partner Antares imply Teva is confident FDA approval is imminent.
EpiPen

FDA's New Guidance May Foster More Auto-Injector and Inhaler Competition

Dave Bloom -
Changes will pave way for faster introduction of new products and relaxed rules for substitutability.
Teva Generic

Epinephrine Auto-injectors: Where is the Long Promised Generic?

Dave Bloom -
We were supposed to have a generic alternative last year. What's holding it up and when can we expect it?
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