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Linjeta Approval Status

  • FDA approved: No
  • Brand name: Linjeta
  • Generic name: human insulin [rDNA origin]
  • Dosage form: Injection
  • 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, 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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