Brief: Eagle Pharma Reports Submission Of NDA To U.S. FDA For Landiolol

Eagle Pharmaceuticals

01/06/2022 12:47

June 1 (Reuters) - Eagle Pharmaceuticals Inc  EGRX.O :
    * EAGLE PHARMACEUTICALS ANNOUNCES SUBMISSION OF NEW DRUG
APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR LANDIOLOL,
A BETA-1 ADRENERGIC BLOCKER
    * EAGLE PHARMACEUTICALS INC - IF LANDIOLOL IS APPROVED,
EAGLE
EXPECTS FIVE YEARS OF NEW CHEMICAL ENTITY EXCLUSIVITY
    * EAGLE - EXPECTED APPROVAL MID-YEAR 2023, IF ACCEPTED BY
FDA FOR
FILING, BASED ON FEEDBACK FROM FDA PROVIDED DURING AOP HEALTH'S
TYPE C MEETING
    * EAGLE PHARMACEUTICALS - ENROLLMENT OF STUDY OF PEDIATRIC
PATIENTS WITH SUPRAVENTRICULAR TACHYCARDIA IS UNDERWAY IN EUROPE
    * EAGLE PHARMACEUTICALS- FDA HAS TENTATIVELY AGREED THAT
STUDY
COULD FORM BASIS FOR PROPOSED PEDIATRIC STUDY PLANS FOR A FUTURE
SUBMISSION TO FDA

Source text for Eikon:  ID:nGNX1zzqsC 
Further company coverage:  EGRX.O 

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