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Linjeta Approval Status

Linjeta (human insulin [rDNA origin]) is a modified form of recombinant human insulin designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs. Linjeta is under review as a treatment for diabetes.

Development Status and FDA Approval Process for Linjeta

Nov  1, 2010FDA Issues Complete Response Letter to Biodel Regarding New Drug Application for Linjeta
Mar  1, 2010FDA Accepts VIAject NDA for Review
Jan  5, 2010Biodel Submits VIAject New Drug Application to FDA for Treatment of Diabetes

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