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Eisai gets FDA Complete Response Letter for AcipHex NDA.
(From Pharma)
M2PHARMA-February 2, 2011-Eisai gets FDA Complete Response Letter for AcipHex NDA (C)2011 M2 COMMUNICATIONS http://www.m2.com
2 February 2011 - Japanese pharmaceutical company Eisai Co Ltd (TYO: 4523) said today that its US subsidiary Eisai Inc has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) of AcipHex extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI).
AcipHex is currently under review for the healing and long-term maintenance of healing and symptom resolution of erosive gastroesophageal reflux disease (GERD), and for the …
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