Linjeta FDA Approval Status
Linjeta (human insulin [rDNA origin]) is an investigational rapid-acting insulin analog intended for use in the treatment of type 1 and type 2 diabetes.In November 2010, Biodel, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration requesting additional information regarding the company's new drug application (NDA) for Linjeta. The CRL stated the NDA could not be approved in its present form.
Development Timeline 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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