Linjeta Approval Status
- FDA approved: No
- Brand name: Linjeta
- Generic name: insulin
- Previous name: VIAject
- Company: Biodel, Inc.
- Treatment for: Diabetes, Type 1, Diabetes, Type 2
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.
FDA Approval Status for Linjeta
|Nov 1, 2010||FDA Issues Complete Response Letter to Biodel Regarding New Drug Application for Linjeta|
|Mar 1, 2010||FDA Accepts VIAject NDA for Review|
|Jan 5, 2010||Biodel Submits VIAject New Drug Application to FDA for Treatment of Diabetes|
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