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Mycapssa Approval Status

  • FDA approved: No
  • Brand name: Mycapssa
  • Generic name: octreotide
  • Company: Chiasma, Inc.
  • Treatment for: Acromegaly

Mycapssa (octreotide) is an oral formulation of the somatostatin analog octreotide (currently available as an injection) in development for the treatment of acromegaly.

On April 15, 2016, Chiasma, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application for Mycapssa (octreotide) capsules for the maintenance treatment of adult patients with acromegaly. The FDA issues CRLs to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.

Development Status and FDA Approval Process for Mycapssa

DateArticle
Apr 15, 2016FDA Issues Complete Response Letter for Mycapssa New Drug Application
Aug 17, 2015Chiasma Announces FDA Acceptance For Filing of New Drug Application for Octreotide Capsules in Acromegaly
Jun 15, 2015Chiasma Submits New Drug Application to U.S. FDA for Octreotide Capsules in Acromegaly

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