CHADDS FORD, Pa., Jan. 31, 2011 /PRNewswire/ -- Endo Pharmaceuticals (Nasdaq: ENDP) announced today that its partners, Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc., have received a Paragraph IV Certification Notice from Mylan Technologies Inc. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of LIDODERM® (lidocaine topical patch 5%).
The company is currently reviewing the details of this notice from Mylan. Endo intends to vigorously defend LIDODERM's intellectual property rights and will pursue all available legal and regulatory pathways in defense of LIDODERM.
The Paragraph IV certification notice refers to U.S. Patent Nos. 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. These patents are listed in the U.S. Food and Drug Administration's (FDA) Orange Book and expire in March 2014 and October 2015, respectively.
Citizen Petition
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. 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. 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.
About Endo
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. 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. 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. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries HealthTronics, Inc. and Qualitest Pharmaceuticals, please visit www.endo.com.
Save A Life - Endometriosis Awareness. Please help spread the word and join us in our campaign Awareness in the fight against ENDOMETRIOSIS! In appreciation for your support, we offer one (1) free bookmark for every ten (10) leads or one (1) free book for every five (5) books purchased by you and your direct referrals – just e-mail leads/referrals with our link and ask them to Subscribe (opt-in) to our blog or Connect With Us and then send a private e-mail to JaimiTaylor@yahoo.com with full contact information for you and your leads/referrals.
Blog Format. Each month we will touch on a new informative theme/topic related to endometriosis. Daily we will post a short title and "question of the day" followed by a discussion and recap of Book Synopsis below for reference.
Suggestions Welcomed. Leave a Comment or send a private e-mail to JaimiTaylor@yahoo.com with full contact information and receive entry in our monthly free drawing to win a book.
DERAILED Memoirs of a Botched Hysterectomy - Hysterectomy to Remove Fibroids and Cyst - Really was ENDOMETRIOSIS! How does an outwardly healthy 47-year old woman's "routine hysterectomy" become an 18-day ordeal spanning 2 hospitals, 4 surgeries, and $400,000 in medical bills?
DERAILED is a true story - one woman's terrifying journey through a seemingly endless comedy of errors, miss-diagnosis, and near-death experiences. The reader will find themselves immersed in the constant stream of turmoil experienced by the unsuspecting patient; including cover ups, good doctors protecting bad doctors, and hospitals pitted against the other. Who is she? She is any woman, anywhere and everywhere.
Written by a woman unwilling to give up, the author's light hearted approach will endear you to the class and dignity she portrays; including scores of useful medical facts based upon subsequent research in the areas of fibroids, cysts, endometriosis, blood transfusions, drugs, blood clots, bypass implants, and more - all things she endured as a result of a so called "routine hysterectomy."
No comments:
Post a Comment