Linjeta Approval Status
- FDA approved: No
- Brand name: Linjeta
- Generic name: human insulin [rDNA origin]
- Previous name: VIAject
- Company: Biodel, Inc.
- Treatment for: Diabetes, Type 1, Diabetes, Type 2
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 Status and FDA Approval Process 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|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.