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Mycapssa FDA Approval History

FDA Approved: Yes (First approved June 26, 2020)
Brand name: Mycapssa
Generic name: octreotide
Dosage form: Delayed-Release Capsules
Company: Chiasma, Inc.
Treatment for: Acromegaly

Mycapssa (octreotide) is an oral formulation of the approved somatostatin analog octreotide for the treatment of acromegaly.

Development Timeline for Mycapssa

DateArticle
Jun 26, 2020Approval FDA Approves Mycapssa (octreotide) Oral Somatostatin Analog for Acromegaly
Jan 13, 2020Chiasma Announces FDA Acceptance of Mycapssa New Drug Application Resubmission
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

Further information

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