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Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted

 
• By Bridget Silverman

The latest regulatory news on new versions of complex products and delivery systems from our FDA Performance Tracker.

Keeping Track Feature image

Alternative versions and formulations of tough-to-copy products took center stage in US FDA's review and approval activity as FDA approved Adamis Pharmaceuticals Corp.'s epinephrine pre-filled syringes, accepted Sandoz Inc.'s ANDA for a generic version of GlaxoSmithKline PLC's Advair Diskus, and issued a complete response letter for Coherus BioSciences Inc.'s biosimilar pegfilgrastim.

FDA approved Adamis' epinephrine pre-filled syringe (PFS) product for emergency allergy treatment on June 15, 2017 – three years and three review cycles after the company submitted an NDA under the 505(b)(2) pathway on May 28, 2014

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