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August 4, 2014
08:31 EDTIPXLImpax reports FDA re-inspected its manufacturing facility in California
Impax Laboratories announced that the FDA performed a re-inspection of the Company's Hayward, California manufacturing facility from June 16 to July 31. At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations. The FDA did not provide any status or classification to these observations and, pursuant to its established regulatory process, will defer classification until it has reviewed the Company's response to the inspection.
News For IPXL From The Last 14 Days
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November 25, 2015
07:32 EDTIPXLImpax granted EC marketing authorization for Numient
Impax announced that the European Commission has granted marketing authorization for Numient, a modified-release oral capsule formulation for the symptomatic treatment of adult patients with Parkinson's disease. The review of this application was conducted under the centralized licensing procedure as a therapeutic innovation, and is applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. The EC decision is based on results from three Phase 3 controlled clinical studies which assessed the safety and efficacy of Numient in patients with early and advanced Parkinson's disease in the U.S. and in Europe.
06:04 EDTIPXLMylan and Perrigo set to face-off over potential targets, Bloomberg reports
Mylan (MYL) will likely find itself now competing with Perrigo (PRGO) for other assets, reports Bloomberg. According to Bloomberg Intelligence analyst Elizabeth Krutoholow, both companies may look to buy Impax Laboratories (IPXL), Stada Arzneimittel or Taro Pharmaceutical Industries (TARO). All of the potential targets are attractive due to their over-the-counter products. Reference Link
November 24, 2015
09:05 EDTIPXLImpax receives FDA approval for generic version of dutasteride capsules
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November 16, 2015
07:16 EDTIPXLHayman Capital gives quarterly update on stakes
NEW STAKES: Impax (IPXL), CF Industries (CF), GW Pharmaceuticals (GWPH), ProNAi Therapeutics (DNAI). INCREASED STAKES: BioMarin (BMRN), NMI Holdings (NMIH), Vertex (VRTX), Endo (ENDP). DECREASED STAKES: Mylan (MYL). LIQUIDATED STAKES: Perrigo (PRGO), Oasis Petroleum (OAS), Whiting Petroleum (WLL), Newfield Exploration (NFX), SM Energy (SM).

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