Investors should note that many factors could affect the business combination of the companies, future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in this press release. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Statements including words such as 'believes,' 'expects,' 'anticipates,' 'intends,' 'estimates,' 'plan,' 'will,' 'may' 'intend,' 'guidance' or similar expressions are forward-looking statements. This press release contains forward-looking statements regarding, among other things, Endo's financial position, results of operations, market position, product development and business strategy, as well as estimates of Endo's future total revenues, future expenses, future net income and future earnings per share. and Qualitest Pharmaceuticals, please visit Forward-Looking Statements For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries HealthTronics, Inc. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. To ensure the safe and effective equivalence of any generic version to LIDODERM, which acts locally in the skin, Endo believes that FDA must return to its established standard of clinical endpoint bioequivalence studies.Įndo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. The company is requesting that the agency reconsider its departure from its longstanding general rule of requiring clinical endpoint bioequivalence studies for locally acting topical generic drug products, including those that reference LIDODERM. With respect to Endo's regulatory approach, the company submitted a Citizen Petition in 2006 in reaction to a proposal by FDA's Office of Generic Drugs that would diverge from applicable regulations and standards of practice regarding bioequivalence. Food and Drug Administration's (FDA) Orange Book and expire in March 2014 and October 2015, respectively. 5,741,510 and 5,827,529, which cover the formulation of LIDODERM, a topical patch to relieve the pain of postherpetic neuralgia launched in 1999. The Paragraph IV certification notice refers to U.S. Endo intends to vigorously defend LIDODERM's intellectual property rights and will pursue all available legal and regulatory pathways in defense of LIDODERM. The company is currently reviewing the details of this notice from Mylan. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of LIDODERM® (lidocaine topical patch 5%). and Teikoku Pharma USA, Inc., have received a Paragraph IV Certification Notice from Mylan Technologies Inc. 31, 2011 /PRNewswire/ - Endo Pharmaceuticals (Nasdaq: ENDP) announced today that its partners, Teikoku Seiyaku Co., Ltd.

Endo pharmaceuticals news