Statement on FDA Decision Regarding Endo Citizen Petition and Approval of a Generic Formulation of LIDODERM®
CHADDS FORD, Pa., Aug. 23, 2012 /PRNewswire/ -- Endo Health Solutions (Nasdaq: ENDP) today issued the following statement regarding the U.S. Food and Drug Administration's (FDA) response to Endo's Citizen Petition (CP) related to the approval requirements for generic versions of LIDODERM (lidocaine patch 5%), a locally-acting topical medication for the relief of pain associated with post-herpetic neuralgia.
"We are disappointed in FDA's decision to deny the citizen petition and approve a generic version of LIDODERM. The company believes that the approval of a generic version of LIDODERM without requiring clinical endpoint studies is inadequate to establish the safety and efficacy of this locally-acting topical medication. The company anticipated the possibility of generic competition for LIDODERM in September of 2013 pursuant to its settlement agreement with Watson Pharmaceuticals and has been proactively preparing for the event."
Endo Health Solutions (Endo) is a US-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Through our operating companies: AMS, Endo Pharmaceuticals, HealthTronics and Qualitest, Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates maximum value for patients, providers and payers alike. Learn more at www.endo.com.
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SOURCE Endo Health Solutions