Sucampo Pharma Europe Ltd., a subsidiary of Sucampo Pharmaceuticals, Inc. (SCMP), announced that it has received marketing authorization from Swissmedic, the Swiss Agency for Therapeutic Products for its Amitiza 24 microgram gel capsules for the long-term treatment of patients with chronic idiopathic constipation.
The approval is the first European regulatory approval for Sucampo and Amitiza is the first prescription medicine to be approved in Switzerland for the long-term treatment of CIC. Amitiza is already approved by the U.S. Food and Drug Administration for the long-term treatment of CIC in adults and for the treatment of irritable bowel syndrome with constipation in adult women. Amitiza is the only prescription medicine approved by the FDA for either of these indications.
Sucampo is now working on the next steps toward pricing and reimbursement to determine distribution alternatives. Sucampo's goal is to have Amitiza available for eligible patients in Switzerland.
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