Drug Industry Daily

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Generic-drug makers must submit self-identification information to the FDA by Dec. 3 to comply with the recently passed Generic Drug User Fee Amendments of 2012.

A sharp increase in exaggerated or misleading comparative claims in drug advertisements has the FDA analyzing the issue and considering guidance on it to help stop the violations.

Novo Nordisk has discontinued development of one of its four hemophilia drug candidates following data from a Phase IIIa trial that found anti-drug antibodies and further potential risks for hemophilia patients with inhibitors.

The European Medicines Agency (EMA) will soon allow biosimilars sponsors to reference biologics made outside the European Economic Area (EEA) in some preclinical and clinical studies required for approval.

Mylan is set to begin shipping its generic versions of Sanofi’s hypertension treatments Avapro and Avalide following the FDA’s Friday approval of the company’s ANDAs.