Endo International PLC (ENDP.O) Key Developments | Reuters.com
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Endo International PLC (ENDP.O)

ENDP.O on Nasdaq

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27 Jun 2016
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Latest Key Developments (Source: Significant Developments)

Endo says FDA advisory committee for Opana will be convened in fall of 2016
Wednesday, 15 Jun 2016 08:30am EDT 

Endo Pharmaceuticals Inc : Has been notified that an advisory committee of FDA will be convened in fall of 2016 . Advisory committee of FDA will be convened to review company's supplemental new drug application (SNDA) for Opana® ER .Current prescription drug user fee act (PDUFA) date of july 29, 2016 for Opana ER SNDA will not be met.  Full Article

Monosol Rx wins patent infringement suit against Par pharma, Watson pharma
Tuesday, 7 Jun 2016 11:04am EDT 

Monosol Rx : Monosol Rx Wins Patent Infringement Suit Against Par Pharmaceutical And Watson Pharmaceuticals Related To Suboxone Sublingual Film .Ruling Expected To Prevent Generic Buprenorphine, Naloxone Film Products From Entering Market Prior To The Patent’S Expiration In 2024.  Full Article

Endo International PLC - U.S. FTC sues Endo for violating antitrust laws - Reuters News
Thursday, 31 Mar 2016 10:01am EDT 

Endo International PLC:The U.S. Federal Trade Commission said it filed a complaint in a district court accusing some drugmakers, including Endo International Plc, of violating antitrust laws by striking deals to block consumers' access to generic copies of their drugs - RTRS.The FTC's complaint alleges that Endo paid the first generic companies that filed for FDA approval – Impax Laboratories Inc IPXL.O and Watson Laboratories, a unit of Allergan Plc AGN.N – to eliminate the risk of competition for two of its pain drugs.  Full Article

Endo International PLC - Endo Health to pay $39 mln over fluoride labeling claims - Reuters
Wednesday, 16 Dec 2015 04:37pm EST 

Endo International PLC:A generic drug maker owned by Endo International Plc ENDP.O has reached a $39 million settlement with the U.S. government and 47 states stemming from the unlawful labeling of multivitamins that contained fluoride. - RTRS.New York Attorney General Eric Schneiderman announced the settlement on Wednesday. The case stemmed from a 2013 whistleblower lawsuit filed under the False Claims Act in which the U.S. Department of Justice and state attorneys general later intervened. - RTRS.  Full Article

Endo International PLC announces extension of U.S. Rights For Voltaren Gel
Monday, 14 Dec 2015 08:00am EST 

Endo International PLC:Announced the extension of its exclusive U.S. marketing rights for the currently marketed prescription medicine Voltaren Gel.Says agreement grants exclusive license to commercialize branded product and any future authorized generic until 2023.Through indirect wholly owned subsidiary, entered into licensing agreement with sandoz and novartis ag through june 30, 2023.  Full Article

Endo International PLC Announces It Will Enter Into Up To $250 Million Share Repurchase Program
Friday, 6 Nov 2015 04:32pm EST 

Endo International PLC:Says announced that it will enter into a program to repurchase up to $250 million of its common stock under a previously authorized $2.5 billion repurchase plan.Endo will enter into the program on November 9, 2015 and will begin repurchasing the shares as soon as practicable thereafter, in accordance with the program's terms.It is anticipated that the purchases will be completed by the end of 2015 and will be funded through available liquidity.  Full Article

Endo International PLC says U.S. FDA Approves BELBUCA (buprenorphine) Buccal Film for Chronic Pain Management
Monday, 26 Oct 2015 06:00am EDT 

Endo International PLC:U.S. FDA approves Belbuca(TM) (buprenorphine) buccal film for chronic pain management.Belbuca(TM) is expected to be commercially available in the U.S during the first quarter of 2016.FDA approval of Belbuca(TM) was based on two double-blind, randomized, placebo-controlled, enriched-enrollment phase 3 studies.  Full Article

Endo International PLC completes acquisition of broad portfolio of branded and generic products from Aspen Holdings
Thursday, 1 Oct 2015 12:00am EDT 

Endo International PLC:Says completed previously announced acquisition of broad portfolio of branded and generic injectable and established products focused on pain, anti-infectives, cardiovascular and other specialty therapeutics areas from a subsidiary of Aspen Holdings.  Full Article

Endo International PLC completes acquisition of par pharmaceutical
Monday, 28 Sep 2015 06:30am EDT 

Endo International PLC:Completes acquisition of par pharmaceutical and provides financial guidance.Co's combined US generics segment to be named par pharmaceutical; to be led by paul campanelli, former CEO of par pharmaceutical.  Full Article

Endo International PLC raises FY 2015 guidance; gives FY 2016 EPS guidance above analysts' estimate
Monday, 28 Sep 2015 06:30am EDT 

Endo International PLC:Now expects FY 2015 Total revenue to be between $3.22 billion and $3.27 billion.Expects FY 2015 Adjusted diluted EPS from continuing operations to be between $4.50 and $4.60 compared to $4.40 and $4.60 estimated in previous guidance.Expects FY 2016 adjusted diluted EPS from continuing operations to be between $5.85 and $6.15.FY 2015 revenue of $2.96 billion and EPS of $4.52 - Thomson Reuters I/B/E/S.FY 2015 EPS of $5.71 - Thomson Reuters I/B/E/S.  Full Article

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Highlights: Top U.S. hedge funds bet on Alphabet, Netflix and retailers

NEW YORK Former SAC executive Gabe Plotkin's Melvin Capital took a new position in streaming video service Netflix Inc, buying 950,000 shares and a call option for 1.45 million shares, according to regulatory filings on Monday. Melvin Capital also took a new position in Home Depot Inc, buying 475,000 shares. And Passport Capital added 3.3 million Yahoo Inc shares, upping its stake by 243 percent, filings show.