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Friday, January 06, 2017 1:10:37 PM
FDA has provided communication in March 2013
"Based on the FDA's preliminary review and comments on the Company's ANDA for generic Pristiq®, the Company plans to repeat one of three bioequivalence studies for the product candidate. The Company will amend its existing application for generic Pristiq® to include the new study upon its successful completion."
By May 1st two additional anda approvals likely!
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