EMA Adopts Positive Opinion For Several New Drugs, To Recall Vimpat

The European Medicines Agency or EMA, Friday said the Committee for Medicinal Products for Human Use, or CHMP, adopted positive opinion for several medicines for granting marketing authorizations during July, and added that CHMP will recall Vimpat 15 mg/ml syrup because of a quality defect in some batches leading to uneven distribution of the active substance lacosamide in the syrup.

MAIN FACTS:

-Committee adopted positive opinions recommending the granting of marketing authorisations for the following new medicines:

* Dexdor, dexmedetomidine, from Orion Corporation.

* Incivo, telaprevir, from Janssen-Cilag International NV.

* Plenadren, hydrocortisone, an orphan medicine from DuoCort Pharma AB.

* Vyndaqel tafamidis, from Pfizer Specialty U.K. Ltd.

* Zytiga, abiraterone acetate, from Janssen-Cilag International NV.

-Committee has adopted the second positive opinion for a paediatric-use marketing authorisation, for the orphan medicine Mercaptopurine Nova Laboratories, mercaptopurine monohydrate, from Nova Laboratories Ltd.

-Committee adopted a negative opinion recommending that no marketing authorization should be granted for Sumatriptan Galpharm, sumatriptan, from Galpharm Healthcare Ltd.

-Committee adopted positive opinions recommending the granting of marketing authorizations for the following generic medicines:

* Levetiracetam Accord, levetiracetam, from Accord Healthcare Ltd.

* Levetiracetam Actavis, levetiracetam, from Actavis Group PTC ehf.

* Matever, levetiracetam, from Pharmathen S.A.

* Pioglitazone Accord, pioglitazone hydrochloride, from Accord Healthcare Ltd.

* Pioglitazone ratiopharm, pioglitazone, from ratiopharm GmbH.

* Pioglitazone ratiopharm GmbH, pioglitazone, from ratiopharm GmbH.

* Pioglitazone ratio, pioglitazone, from ratiopharm GmbH.

* Paglitaz, pioglitazone, from Krka d.d. Novo mesto.

* Pioglitazone Krka, pioglitazone, from Krka d.d. Novo mesto.

* Pramipexole Accord, pramipexole, from Accord Healthcare Ltd

* Telmisartan Teva Pharma, telmisartan, from Teva Pharma B.V.

-Committee adopted positive opinions for the following applications for extension of the therapeutic indications:

* Afinitor, everolimus, from Novartis Europharm Ltd.

* Enbrel, etanercept, from Wyeth Europa Ltd.

* Tarceva, erlotinib, from Roche Registration Ltd.

-Committee adopted negative opinions for Ariclaim, Cymbalta and Xeristar, all from Eli Lilly Nederland B.V.

-Committee has been informed by Genzyme Europe B.V., the marketing authorization holder for Thyrogen that the supply shortage for this medicine will continue for longer than anticipated.

-Committee completed an arbitration procedure initiated by Malta because of a disagreement among E.U. Member States regarding the authorisation of the generic medicine Dexamethasone Alapis from Alapis S.A.

-Committee recommended harmonisation of the prescribing information for Norvasc and associated names, from Pfizer group of companies.

-By Tapan Panchal, Dow Jones Newswires. Tel +44(0)207-842 9448, tapan.panchal@dowjones.com

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