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

Pfizer begins a Phase 1/2 study to evaluate respir…

Pfizer Inc. (NYSE:PFE) today announced that it has started a Phase 1/2 trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy adult volunteers. RSV i...

Eczema drug effective against severe asthma

Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients' ability to breathe bett...

Most popular vitamin and mineral supplements provi…

The most commonly consumed vitamin and mineral supplements provide no consistent health benefit or harm, suggests a new study led by researchers at St. Michael's Hospital...

AstraZeneca heads to 2018 ASCO Annual Meeting with…

AstraZeneca and MedImmune, its global biologics research and development arm, head to the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US...

Tiny particles could help fight brain cancer

Glioblastoma multiforme, a type of brain tumor, is one of the most difficult-to-treat cancers. Only a handful of drugs are approved to treat glioblastoma, and the median ...

Novartis data at ASCO and EHA reinforce company's …

Novartis will present data from across its oncology portfolio at the upcoming 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 1-5 ...

Spiolto® Respimat® enables greater physical activi…

Boehringer Ingelheim announced data which add to the growing body of evidence that show Spiolto® (tiotropium/olodaterol) Respimat® enables greater physical activity in pa...

New approach to immunotherapy leads to complete re…

A novel approach to immunotherapy developed by researchers at the National Cancer Institute (NCI) has led to the complete regression of breast cancer in a patient who was...

Amgen Foundation and Harvard team up to offer free…

The Amgen Foundation and Harvard University today announced plans to launch a free online science education platform uniquely designed to level the playing field for aspi...

The Pfizer Foundation announces $5 million in gran…

The Pfizer Foundation announced a new $5 million grant commitment to initiatives in low- and middle-income countries that provide family planning access and education for...

Study demonstrates new treatment for severe asthma

Researchers from McMaster University and the Firestone Institute for Respiratory Health at St. Joseph's Healthcare Hamilton, together with colleagues at other partnering ...

Study finds antioxidant-enriched vitamin reduces r…

Researchers at Children's Hospital Colorado (Children's Colorado) and the University of Colorado School of Medicine have found that taking a specially formulated antioxid...