Watson Pharma (WPI) Says Generic Lidoderm ANDA 'On Track'; Will Not Comment Further
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In response to investment community speculation following release of the transcript of a pre-trial conference call related to its Lidoderm patent challenge, Watson Pharmaceuticals, Inc. (NYSE: WPI) today issued the following statement:
"Watson's abbreviated new drug application (ANDA) for a generic version of Lidoderm remains on track. We believe questions related to the site where a biostudy supporting the ANDA was conducted have been addressed to FDA's satisfaction. We continue to work closely with the FDA with the goal of timely approval. Watson has made public comments throughout the year regarding our Lidoderm application, including most recently at our analyst day on January 24th, where the Company restated our confidence that a tentative approval for generic Lidoderm will be received prior to the 30-month stay expiry on July 15, 2012.
"In order not to affect the pending patent litigation trial, it is our policy not to comment during litigation. Therefore, we will not provide additional comment on details that may arise during the trial."
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"Watson's abbreviated new drug application (ANDA) for a generic version of Lidoderm remains on track. We believe questions related to the site where a biostudy supporting the ANDA was conducted have been addressed to FDA's satisfaction. We continue to work closely with the FDA with the goal of timely approval. Watson has made public comments throughout the year regarding our Lidoderm application, including most recently at our analyst day on January 24th, where the Company restated our confidence that a tentative approval for generic Lidoderm will be received prior to the 30-month stay expiry on July 15, 2012.
"In order not to affect the pending patent litigation trial, it is our policy not to comment during litigation. Therefore, we will not provide additional comment on details that may arise during the trial."
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