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Amneal Pharmaceuticals Inc (AMRX.N)

AMRX.N on New York Stock Exchange

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21 Sep 2018
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Latest Key Developments (Source: Significant Developments)

Amneal Announces FDA Approval And Launch Of Generic Chlorpromazine Hydrochloride Tablets Usp And Approval Of Methylergonovine Maleate Tablets Usp
Wednesday, 12 Sep 2018 

Sept 12 (Reuters) - Amneal Pharmaceuticals Inc ::AMNEAL ANNOUNCES FDA APPROVAL AND LAUNCH OF GENERIC CHLORPROMAZINE HYDROCHLORIDE TABLETS USP AND APPROVAL OF METHYLERGONOVINE MALEATE TABLETS USP.  Full Article

Amneal Announces Partnership With American Regent
Friday, 31 Aug 2018 

Aug 31 (Reuters) - Amneal Pharmaceuticals Inc ::AMNEAL ANNOUNCES PARTNERSHIP WITH AMERICAN REGENT ON GENERIC MAKENA® AND PROGRESS ON ITS BUSINESS PLAN WITH ADDITIONAL ANDA APPROVALS AND LAUNCHES.AMNEAL PHARMACEUTICALS INC - WILL DISTRIBUTE A GENERIC VERSION OF MAKENA TO RETAIL CONSORTIUMS.AMNEAL PHARMACEUTICALS INC - RECEIVED APPROVALS FOR TWO NEW TOPICAL PRODUCTS THAT TREAT A VARIETY OF SKIN CONDITIONS.AMNEAL PHARMACEUTICALS INC - WELL-POSITIONED TO ACHIEVE GOAL OF LAUNCHING UP TO 47 NEW PRODUCTS BY END OF YEAR.AMNEAL PHARMACEUTICALS - AMERICAN REGENT WILL MARKET GENERIC VERSION OF MAKENA IN CERTAIN CHANNELS INCLUDING HOSPITAL AND SPECIALTY CHANNELS.AMNEAL PHARMACEUTICALS - ANNOUNCED A 5-YEAR SUPPLY & DISTRIBUTION AGREEMENT WITH AMERICAN REGENT FOR GENERIC ALTERNATIVE TO MAKENA.  Full Article

Amneal Announces Q2 Adjusted Earnings Per Share $0.24
Thursday, 9 Aug 2018 

Aug 9 (Reuters) - Amneal Pharmaceuticals Inc ::AMNEAL ANNOUNCES SOLID SECOND QUARTER 2018 FINANCIAL RESULTS.Q2 REVENUE $413.8 MILLION VERSUS I/B/E/S VIEW $460.8 MILLION.Q2 ADJUSTED EARNINGS PER SHARE $0.24.Q2 GAAP LOSS PER SHARE $0.15.Q2 EARNINGS PER SHARE VIEW $0.22 -- THOMSON REUTERS I/B/E/S.UPDATES 2018 FINANCIAL GUIDANCE.SEES 2018 ADJUSTED EPS $0.90 TO $1.00.AMNEAL PHARMACEUTICALS - SEES 2018 CAPEX $80 MILLION TO $100 MILLION.AMNEAL PHARMACEUTICALS - REVISED 2018 ADJUSTED\EPS GUIDANCE PRIMARILY DUE TO DELAYED TIMING OF DELIVERIES OF EPINEPHRINE AUTO-INJECTOR.  Full Article

Amneal Announces Favorable Ruling Regarding Patent Validity For Zomig Nasal Spray
Friday, 29 Jun 2018 

June 29 (Reuters) - Amneal Pharmaceuticals Inc ::AMNEAL ANNOUNCES FAVORABLE RULING REGARDING PATENT VALIDITY FOR ZOMIG® (ZOLMITRIPTAN) NASAL SPRAY.AMNEAL PHARMA - PANEL OF THREE CIRCUIT JUDGES AFFIRMED RULING THAT LANNETT FAILED TO PROVE U.S. PATENTS PROTECTING ZOMIG NASAL SPRAY WERE INVALID.  Full Article

Amneal Announces Patent Litigation Settlement Agreement With Actavis Concerning Rytary®
Wednesday, 20 Jun 2018 

June 20 (Reuters) - Amneal Pharmaceuticals Inc ::AMNEAL ANNOUNCES PATENT LITIGATION SETTLEMENT AGREEMENT WITH ACTAVIS CONCERNING RYTARY®.AMNEAL PHARMACEUTICALS - UNDER TERMS OF AGREEMENT, AMNEAL WILL GRANT ACTAVIS A LICENSE TO BEGIN SELLING A GENERIC VERSION OF RYTARY ON JULY 31, 2025.AMNEAL PHARMACEUTICALS INC - ADDITIONAL DETAILS REGARDING SETTLEMENT WERE NOT DISCLOSED.AMNEAL PHARMACEUTICALS - LAUNCH OF ACTAVIS'S GENERIC PRODUCT CONTINGENT UPON ACTAVIS GETTING APPROVAL FROM FDA OF ANDA FOR GENERIC VERSION OF RYTARY.  Full Article

Amneal Announces FDA Approval Of Cyclophosphamide For Injection USP, Generic To Cytoxan
Wednesday, 30 May 2018 

May 30 (Reuters) - Amneal Pharmaceuticals Inc ::AMNEAL ANNOUNCES FDA APPROVAL OF CYCLOPHOSPHAMIDE FOR INJECTION USP, GENERIC TO CYTOXAN®.AMNEAL PHARMACEUTICALS INC - COMPANY EXPECTS TO BEGIN SHIPPING PRODUCT SHORTLY.AMNEAL - FDA APPROVAL ON ANDA FOR CYCLOPHOSPHAMIDE FOR INJECTION USP, CO'S AP-RATED THERAPEUTIC EQUIVALENT TO CYTOXAN 500 MG, 1 G, 2 G SINGLE-DOSE VIALS.  Full Article

Amneal Signs Licensing And Supply Agreement For mAbxience's Biosimilar To Roche's Avastin
Wednesday, 23 May 2018 

May 23 (Reuters) - Amneal Pharmaceuticals Inc ::MABXIENCE AND AMNEAL ENTER INTO AN AGREEMENT FOR BEVACIZUMAB BIOSIMILAR IN THE UNITED STATES.MABXIENCE - CO WILL LEAD PRODUCT, CLINICAL DEVELOPMENT AND SUBSEQUENT MANUFACTURE OF BEVACIZUMAB BIOSIMILAR.MABXIENCE - UNDER AGREEMENT, AMNEAL WILL GUIDE PRODUCT THROUGH REGULATORY APPROVAL, HAVE EXCLUSIVE COMMERCIALISATION RIGHTS IN U.S..  Full Article

Amneal And Impax Receive FTC Clearance For Business Combination
Friday, 27 Apr 2018 

April 27 (Reuters) - Impax Laboratories Inc ::AMNEAL AND IMPAX RECEIVE FTC CLEARANCE FOR BUSINESS COMBINATION.CO, AMNEAL EXPECT TO CONSUMMATE BUSINESS COMBINATION FOLLOWING CLOSE OF TRADING ON MAY 4, 2018.  Full Article

Impax Announces Sale Of Taiwan Manufacturing Facility
Tuesday, 19 Dec 2017 

Dec 19 (Reuters) - Impax Laboratories Inc ::IMPAX ANNOUNCES SALE OF TAIWAN MANUFACTURING FACILITY.IMPAX LABORATORIES INC - ‍ ENTERED INTO A DEFINITIVE AGREEMENT TO SELL IMPAX TAIWAN TO BORA PHARMACEUTICALS CO​.IMPAX LABORATORIES - BORA WILL PURCHASE ALL OF ISSUED SHARE CAPITAL IN IMPAX TAIWAN, CERTAIN LOANS OUTSTANDING BETWEEN CO, UNIT FOR $18.5 MILLION..IMPAX LABORATORIES INC - AS A RESULT OF SALE, CO EXPECTS TO RECORD A PRE-TAX IMPAIRMENT CHARGE OF ABOUT $70.0 TO $80.0 MILLION IN Q4 OF THIS YEAR.IMPAX LABORATORIES INC - ‍AS A RESULT OF SALE, CO EXPECTS TO RECORD PRE-TAX IMPAIRMENT CHARGE OF ABOUT $70.0 TO $80.0 MILLION IN Q4 OF THIS YEAR​.IMPAX LABORATORIES INC - ‍ BORA WILL HAVE RIGHTS TO MARKET AND SELL IMPAX'S BRANDED PARKINSON'S DRUG RYTARY IN TAIWAN​.IMPAX - ALSO SIGNED SUPPLY AGREEMENT WITH BORA, EFFECTIVE UPON CLOSING OF TRANSACTION.IMPAX SAYS SIGNED SUPPLY AGREEMENT WITH BORA TO MANUFACTURE, SUPPLY OF CERTAIN OF CO'S MARKETED, DEVELOPMENT PRODUCTS CURRENTLY MANUFACTURED BY UNIT.  Full Article

Impax Receives Tentative fda Approval Of Generic Coreg CR (Carvedilol Phosphate) Extended-Release Capsules
Friday, 8 Dec 2017 

Dec 8 (Reuters) - Impax Laboratories Inc ::IMPAX RECEIVES TENTATIVE FDA APPROVAL OF GENERIC COREG CR® (CARVEDILOL PHOSPHATE) EXTENDED-RELEASE CAPSULES.IMPAX LABORATORIES INC - COMPANY'S ANDA IS ELIGIBLE FOR FINAL APPROVAL UPON EXPIRATION OF MARKETING EXCLUSIVITY ON MAY 7, 2018.  Full Article

UPDATE 2-U.S. court denies Jazz Pharma bid to revive narcolepsy drug patents

July 13 A U.S. appeals court on Friday ruled invalid patents owned by Jazz Pharmaceuticals PLC covering its narcolepsy drug Xyrem, giving Amneal Pharmaceuticals Inc a boost in its effort to launch a generic version of the medicine.