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
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