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Europe’s CHMP Supports Approval of Five Generic Products
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorizations for several generic products. Generic-drug maker Krka received positive opinions for its Enyglid (repaglinide) and Repaglinide Krka, which are versions of Novo Nordisk’s Type 2 diabetes treatment NovoNorm. Teva Pharmaceuticals Europe has received a positive opinion for its generic versions of NovoNorm, Sanofi-Aventis’ hypertension drug Aprovel and GlaxoSmithKline’s Zeffix, which is used to treat chronic hepatitis B. CHMP also recommended approval of Mylan’s clopidogrel besylate, which would compete with Plavix.
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