Elite Pharmaceuticals, Inc. ("Elite" or the “Company") received a Complete Response (CR) from the U.S. Food & Drug Administration (FDA) for its Percocet generic ANDA application. The FDA stated that the response to “the CR letter will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR.” Elite intends to submit a “MINOR AMENDMENT” shortly to address the deficiencies listed. The Percocet generic ANDA submission was received for review by the FDA in November 2016.
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$ELTP has seven days from receipt of the FDA CR MINOR AMENDMENT, for the original Aug 10, 2016 filing, to respond and be received by the FDA.
and it was "officially received" by the FDA for review in November 2016. $ELTP likely received the MINOR AMENDMENT CR FDA document earlier this week. Since $ELTP has seven days for the FDA to officially receive the response, it has likely already been sent to the FDA or is imminent.
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