FDA grants Adamis Pharma. approval for generic version of Epi Pen
Mylan shares are down on the news
Adamis Pharmaceuticals (ADMP) announced that the U.S. Food and Drug Administration has approved Adamis’ Epinephrin Injenction, USP, 1:1000 for the emergency treatment of allergic reactions including anaphylaxis.
The FDA has also approved the PFS trade name of #Symjepi. Symjepi provides two single dose syringes of epinephrine, which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to foods, drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We are very excited by this approval, and at the same time, are already preparing to submit our second NDA to the FDA. This second submission is for the junior version of Symjepi. We are committed to helping patients by providing them with additional therapeutic choices. With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail and non-retail (professional) sectors of the epinephrine market. We are currently in the process of exploring all of our commercialization options and in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset. In the interim, we expect to build inventory levels in preparation for an anticipated launch in the second half of this year.”
Mylan (MYL) shares are down 3% to $36.75. ADMP shares are up 30% to $5.00
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