Actavis files Abbreviated New Drug Application seeking approval for Ambrisentan Tablets.
M2 EQUITYBITES-April 6, 2015-Actavis files Abbreviated New Drug Application seeking approval for Ambrisentan Tablets
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Actavis plc (NYSE: ACT), an Ireland-based global pharmaceutical company, announced on Friday that it has filed an Abbreviated New Drug Application seeking approval with the US Food and Drug Administration to market Ambrisentan Tablets, five mg and 10 mg.
The company's Abbreviated New Drug Application product is a generic version of Gilead Sciences, Inc.'s Letairis(R), which is a treatment for pulmonary arterial hypertension.
The company believes it is likely to be a 'first applicant' to file an Abbreviated New Drug Application for the generic version of Letairis, and should its Abbreviated New Drug Application be approved it is expected to be entitled to 180 days of generic market exclusivity.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Apr 6, 2015|
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