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Janssen Submits NDA for Canagliflozin

Janssen Submits NDA for Canagliflozin  Janssen Research & Development, LLC has submitted a New Drug Application (NDA) to the FDA seeking approval for the use of canagliflozin, an investigational, oral, once-daily, selective sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with type 2 diabetes.

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FDA Approves Two Generics of Clopidogrel (Plavix)

FDA Approves Two Generics of Clopidogrel (Plavix) The US Food and Drug Administration (FDA) has approved 2 generic versions of the ubiquitous anticoagulant clopidogrel (Plavix, Bristol-Meyers Squibb/Sanofi). It is one of the best-selling drugs indicated for patients who have had a recent heart attack or stroke or who have peripheral …

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FDA Panel Gives Nod to New Diet Drug

FDA Panel Gives Nod to New Diet Drug An FDA advisory committee has voted 18-4, with one abstention, in favor of approving lorcaserin hydrochloride (Lorqess). It would be the first new weight loss drug in more than a decade.   

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FDA Okays Levemir for Pregnant Women

FDA Okays Levemir for Pregnant Women  The FDA had approved Levemir (insulin detemir [rDNA origin]) for a pregnancy category B classification, meaning that when used by pregnant women, the insulin did not increase the risk of harm to fetuses. The agency’s decision was based on results of a clinical trial …

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