Back to FDA Approvals 2004
Generic Name: Secretin Synthetic Human
Date of Approval: April 9, 2004
Company: ChiRhoClin, Inc.
Treatment for: Secretin Stimulation Testing
FDA approves Human SecretinThe Food and Drug Administration, Center for Drug Evaluation and Research, Office of Drug Evaluation has issued ChiRhoClin, Inc. an approval for Human Secretin.
The FDA has approved three indications. The indications of Human Secretin are the following:
- Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.
- Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, and
- Stimulation of pancreatic secretion to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).
The FDA stated that they have completed the review of the NDA applications, as amended. The FDA has concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the agreed upon indications.
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