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Akorn Inc (AKRX.OQ)

AKRX.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Akorn Receives FDA Approval For Loteprednol Etabonate Ophthalmic Suspension, 0.5%
Thursday, 18 Apr 2019 

April 18 (Reuters) - Akorn Inc ::AKORN RECEIVES FDA APPROVAL FOR LOTEPREDNOL ETABONATE OPHTHALMIC SUSPENSION, 0.5%.  Full Article

Akorn Receives FDA Approval For Fluticasone Propionate Nasal Spray USP, 50 Mcg Per Spray
Thursday, 18 Apr 2019 

April 18 (Reuters) - Akorn Inc ::AKORN RECEIVES FDA APPROVAL FOR FLUTICASONE PROPIONATE NASAL SPRAY USP, 50 MCG PER SPRAY (OTC).  Full Article

Innovus Pharma Announces FDA Approval Of New ANDA For Supply Of Fluticare
Thursday, 18 Apr 2019 

April 18 (Reuters) - Innovus Pharmaceuticals, Inc. ::INNOVUS PHARMA ANNOUNCES FDA APPROVAL OF NEW ANDA FOR SUPPLY OF FLUTICARE®.INNOVUS PHARMACEUTICALS - FDA APPROVED ABBREVIATED NEW DRUG APPLICATION FOR FLUTICASONE PROPIONATE NASAL SPRAY USP, 50 MCG PER SPRAY OWNED BY AKORN INC.  Full Article

Akorn Appoints Erislandy Dorado-Boladeres As Executive VP Of Global Quality
Thursday, 21 Mar 2019 

March 21 (Reuters) - Akorn Inc ::AKORN INC - APPOINTMENT OF ERISLANDY DORADO-BOLADERES TO POSITION OF EXECUTIVE VICE PRESIDENT OF GLOBAL QUALITY, EFFECTIVE MARCH 25, 2019.  Full Article

Akorn Comments On Favorable Court Order
Friday, 1 Mar 2019 

March 1 (Reuters) - Akorn Inc ::AKORN COMMENTS ON FAVORABLE COURT ORDER.AKORN - "DELAWARE COURT OF CHANCERY HAS DENIED A REQUEST BY FRESENIUS KABI AG TO BRING A FRAUD CLAIM AGAINST AKORN".  Full Article

Akorn Says FDA Issued Co Form 483, Related To Inspection Of Co's Amityville, New York Manufacturing Facility
Thursday, 28 Feb 2019 

Feb 28 (Reuters) - Akorn Inc ::AKORN SAYS FDA ISSUED CO FORM 483 DATED FEB. 13, RELATED TO INSPECTION OF CO'S AMITYVILLE, NEW YORK MANUFACTURING FACILITY IN JAN. AND FEB. OF 2019.AKORN - FDA INSPECTED AMITYVILLE FACILITY & OBSERVED THAT RECORDS ARE NOT KEPT FOR THE MAINTENANCE, CLEANING, SANITIZING AND INSPECTION OF EQUIPMENT.AKORN - FDA OBSERVED ASEPTIC PROCESSING AREAS AT AMITYVILLE FACILITY ARE DEFICIENT REGARDING MAINTENANCE OF EQUIPMENT USED TO CONTROL THE ASEPTIC CONDITIONS.AKORN - FDA INSPECTED AMITYVILLE FACILITY & OBSERVED THAT CONTAINERS & CLOSURES ARE NOT TESTED FOR CONFORMANCE WITH ALL APPROPRIATE WRITTEN PROCEDURES.  Full Article

Akorn Reports Q4 Loss Per Share Of $1.71
Thursday, 28 Feb 2019 

Feb 28 (Reuters) - Akorn Inc ::AKORN PROVIDES FOURTH QUARTER AND FULL YEAR 2018 RESULTS.Q4 LOSS PER SHARE $1.71.Q4 REVENUE $153.4 MILLION VERSUS REFINITIV IBES ESTIMATE OF $164.7 MILLION.Q4 EARNINGS PER SHARE ESTIMATE $0.00 -- REFINITIV IBES DATA.Q4 ADJUSTED NON-GAAP LOSS PER SHARE $0.29 INCLUDING ITEMS.DECIDED TO EXPLORE STRATEGIC ALTERNATIVES TO EXIT OUR INDIA FACILITY.  Full Article

Akorn Comments On Fresenius’ Proposed Amended Claims
Wednesday, 20 Feb 2019 

Feb 20 (Reuters) - Akorn Inc ::AKORN COMMENTS ON FRESENIUS’ PROPOSED AMENDED CLAIMS.AKORN INC - BELIEVES FRESENIUS' PROPOSED AMENDED CLAIMS "MERITLESS AND OVERREACHING", DENIES ALLEGATIONS.  Full Article

Akorn Says FDA Cites Several Violations In Decatur Facility Warning Letter
Wednesday, 9 Jan 2019 

Jan 9 (Reuters) - Akorn Inc ::AKORN - FDA, IN DECATUR FACILITY WARNING LETTER, SAYS OBSERVED SPECIFIC VIOLATIONS REGARDING "POOR ASEPTIC BEHAVIOR", "NON-INTEGRAL CLEANROOM MATERIALS".AKORN - FDA, IN DECATUR FACILITY WARNING LETTER, SAYS OBSERVED SPECIFIC VIOLATIONS REGARDING "INADEQUATE CLEANROOM DESIGN & SMOKE STUDY DEFICIENCIES".AKORN - AS PER FDA, CO FAILED TO FOLLOW APPROPRIATE WRITTEN PROCEDURES AT DECATUR FACILITY TO PREVENT MICROBIOLOGICAL CONTAMINATION OF DRUG PRODUCTS.AKORN - FDA, IN DECATUR FACILITY WARNING LETTER, SAYS OBSERVED SPECIFIC VIOLATIONS REGARDING "ENVIRONMENTAL AND PERSONNEL MONITORING" & CLEANING OPERATIONS.AKORN - AS PER FDA, CO FAILED TO FOLLOW A WRITTEN TESTING PROGRAM DESIGNED TO ASSESS THE STABILITY CHARACTERISTICS OF DRUG PRODUCTS AT DECATUR FACILITY.  Full Article

Akorn Receives FDA Warning Letter
Wednesday, 9 Jan 2019 

Jan 9 (Reuters) - Akorn Inc ::AKORN RECEIVES FDA WARNING LETTER.AKORN INC - WILL RESPOND TO FDA LETTER WITHIN REQUIRED 15 WORKING DAYS.AKORN - RECEIVED WARNING LETTER FROM U.S. FDA RELATED TO AN INSPECTION OF ITS DECATUR, ILLINOIS MANUFACTURING FACILITY IN APRIL AND MAY OF 2018.AKORN INC - EXPECTS TO CONTINUE PRODUCTION AT DECATUR PLANT.  Full Article

UPDATE 2-FDA flags concerns at Akorn's Amityville plant, shares slip

Feb 28 Generic drugmaker Akorn Inc said on Thursday the U.S. Food and Drug Administration had raised concerns about its manufacturing plant in Amityville, New York, that included a lack of records on the maintenance and cleaning of equipment.