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July 29, 2014
08:18 EDTIPXLImpax announces FDA performs inspection on Taiwan facility
Impax announced that the FDA performed a general GMP inspection and a Pre-Approval Inspection for RYTARYTM at the company's Taiwan manufacturing facility from July 21 to July 26. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in September 2009 and by Taiwan FDA in July 2010. The facility currently manufactures 12 products for distribution in the United States. The FDA did not provide any status or classification to these observations and will wait until they have received and reviewed the company's response to provide this information. The Ccmpany has also not been informed by the FDA of the impact this Form 483 may have on RYTARY's October 9 review date under the Prescription Drug User Fee Act.
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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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