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News Breaks
March 18, 2013
11:10 EDTMYLMylan launches generic version of Xopenex inhalation solution
Mylan announced that its subsidiary Mylan Specialty L.P. has received final approval from the U.S. Food and Drug Administration, FDA, for its Abbreviated New Drug Application, ANDA, for Levalbuterol Inhalation Solution.. This product is the generic version of Sunovion's Xopenex Inhalation Solution, which is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL, 0.63 mg/3 mL, and 1.25 mg/3 mL, had U.S. sales of approximately $438.8 million for the 12 months ending Dec. 31, 2012, according to IMS Health. Mylan has begun shipping this product.
News For MYL From The Last 14 Days
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October 23, 2014
08:15 EDTMYLPfizer wins SUTENT patent case In Delaware District Court
Pfizer (PFE) announced today that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering SUTENT capsules. This decision, which is subject to appeal, affirms Pfizer’s right to exclusively provide sunitinib malate as SUTENT to patients through the term of the patent, which expires in 2021. Pfizer filed suit in June 2010 after Mylan (MYL) applied to the U.S. Food and Drug Administration to market a generic version of SUTENT prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering SUTENT.
06:22 EDTMYLMylan, Abbott enter into amendment, still see deal closing in 1Q15
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October 22, 2014
11:59 EDTMYLStocks with call strike movement; MYL AMZN
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09:16 EDTMYLAbbott sees Q4 reported sales growth in high single digits
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October 20, 2014
08:04 EDTMYLGerman fund pressured to sell Mylan stake over drug used in executions, FT says
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07:20 EDTMYLInternational Continence Society to hold annual meeting
ICS Annual Meeting 2014 is being held in Rio de Janeiro, Brazil on October 20-24.

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