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IPXL.pk ($11.50) Impax Labs-IPXL submits additional information to the FDA for generic Opana
Thursday, December 06 2007 - 7:09

IPXL $11.50 $0.10 (%0.88)

<org>IMPAX Laboratories, Inc. announced that it has submitted information to the U.S. Food and Drug Administration in response to the notice of rescission related to IMPAX's Abbreviated New Drug Application for oxymorphone hydrochloride extended-release tablets CII, a generic version of Opana(R) ER. As previously announced, although the ANDA was originally accepted for filing, FDA subsequently rescinded that acceptance for filing notification. The Company believes that it has now submitted all information that the FDA requires to determine that the ANDA is acceptable for filing.