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FDA accepts re filing of NDA for Macrilen (macimorelin) to treat growth hormone deficiency.- Aeterna Zentaris Inc.

Read time: 1 mins
Last updated: 24th Jul 2017
Published: 24th Jul 2017
Source: Pharmawand

Aeterna Zentaris Inc. announced that it has been notified by the FDA, that the Company�s New Drug Application seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults has been accepted as a complete response to the FDA�s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017.

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