Sanofi Pharma Bristol-Myers Squibb SNC withdraws its marketing authorisation for DuoPlavin

The European Medicines Agency (EMEA)The European Medicines Agency (EMEA) has been formally notified by Sanofi Pharma Bristol-Myers Squibb SNC of its decision to withdraw its application for a centralised marketing authorisation for the medicine DuoPlavin (fixed-dose combination tablets of 75 mg clopidogrel/75 mg acetylsalicylic acid and 75 mg clopidogrel/100 mg acetylsalicylic acid). DuoPlavin was expected to be used by patients already taking clopidogrel and acetylsalicylic acid for the approved indication of prevention of atherothrombotic events in acute coronary syndrome.

The application for marketing authorisation for DuoPlavin was submitted to the EMEA on 30 May 2007. At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

In its official letter, the company stated that the withdrawal of DuoPlavin was based on the request of the CHMP regarding the need to document bioequivalence based on the current guideline on bioavailability and bioequivalence. The company informed in the letter that it intends to perform a new bioequivalence study measuring plasma levels of clopidogrel parent compound to address the CHMP's request but the results of that study will not be available in the timelines defined by the centralised procedure.

More information about DuoPlavin and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website shortly.

For further information, please visit:
http://www.emea.europa.eu

Most Popular Now

Fasenra (benralizumab) receives US FDA approval fo…

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab)...

Pfizer receives FDA approval for SUTENT® (sunitini…

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration has approved a new indication expanding the use of SUTENT® (sunitinib malate) to include...

Alzheimer's disease might be a 'whole body' proble…

Alzheimer's disease, the leading cause of dementia, has long been assumed to originate in the brain. But research from the University of British Columbia and Chinese scie...

Cancer cells destroyed with dinosaur extinction me…

Cancer cells can be targeted and destroyed with the metal from the asteroid that caused the extinction of the dinosaurs, according to new research by an international col...

Novartis confirms leadership in multiple sclerosis…

Novartis today announced it will present 54 scientific abstracts from across its multiple sclerosis (MS) research portfolio at the 7th Joint European and Americas Committ...

Amgen and Novartis announce expanded collaboration…

Amgen (NASDAQ:AMGN) and Novartis announced an expanded collaboration with the Banner Alzheimer's Institute (BAI) to initiate a new trial - the Alzheimer's Prevention Init...

Transplanted hematopoietic stem cells reverse dama…

Researchers at University of California San Diego School of Medicine report that a single infusion of wildtype hematopoietic stem and progenitor cells (HSPCs) into a mous...

Novartis announces the planned acquisition of Adva…

Novartis announced today, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender...

New tissue-engineered blood vessel replacements on…

Researchers at the University of Minnesota have created a new lab-grown blood vessel replacement that is composed completely of biological materials, but surprisingly doe...

'Precision Medicine' may not always be so precise

Precision Medicine in oncology, where genetic testing is used to determine the best drugs to treat cancer patients, is not always so precise when applied to some of the w...

New US study reveals key reasons why millions of p…

Few of the more than 90 million Americans(1) with obesity are seeking and receiving long-term obesity care, according to new data from the Awareness, Care and Treatment I...

Efficacy and safety maintained in patients who swi…

Boehringer Ingelheim today announced one-year data from VOLTAIRE®-RA, a pivotal Phase III clinical trial comparing Cyltezo® (adalimumab-adbm) and reference product Humira...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]