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FDA Rejects Approval of Epinephrine Alternative to EpiPen for Severe Allergic Reactions

FDA Rejects Approval of Epinephrine Alternative to EpiPen for Severe Allergic Reactions
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Grossig david dworaczykRichard lowenthalAllergy drug advisory committeeAdvisory committeeAdvisory committee votes in support of favorableDrug administrationComplete response letterNew drugFormal dispute resolution requestNew drug applicationCommittee votesFavorable benefit risk profileAllergic reactionsIncluding anaphylaxisPublished mayEpinephrine nasal

FDA Declines to Approve of Epinephrine Alternative to EpiPen, Requests Further Study

The FDA's announcement requesting further study represents a step back in the process of 'neffy' becoming the first needle-free nasal spray epinephrine alternative.

Richard lowenthalGrossig david dworaczykAdvisory committee votes in support of favorableAllergy drug advisory committeeDrug administrationAdvisory committeeComplete response letterNew drugFormal dispute resolution requestNew drug applicationCommittee votesFavorable benefit risk profileAllergic reactionsIncluding anaphylaxisPublished mayEpinephrine nasal

FDA Committee Votes in Favor of Intranasal Epinephrine for Severe Allergic Reactions Including Anaphylaxis

It was announced by ARS Pharmaceuticals, Inc., that a US Food and Drug Administration Drug Advisory Committee voted in favor of a new intranasal epinephrine treatment for severe allergic reactions.

United statesRichard lowenthalGrossig david dworaczykDrug administrationAllergy drug advisory committeeAdvisory committee votes in support of favorablePharmaceuticals incPulmonary allergy drug advisory committeeNew drug applicationDrug user fee actChief executive officerCommittee votesFavorable benefit risk profileAllergic reactionsIncluding anaphylaxisPublished may

David Dworaczyk, PhD, Shares New Data on Nasal Epinephrine for Anaphylaxis

Data presented at the American Society for Clinical Pharmacology and Therapeutics annual meeting show promise for Utuly, a novel intranasal epinephrine spray for treating anaphylaxis.

United statesDavid dworaczykGrossig david dworaczykAmerican academy of allergyAmerican society for clinical pharmacologyDrug administrationAmerican societyClinical pharmacologyBryn pharmaAmerican academyPresents phaseNovel intranasal