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SCMP > SEC Filings for SCMP > Form 8-K on 22-Jul-2014All Recent SEC Filings




Other Events

Item 8.01. Other Events.

On July 15, 2014, Sucampo Pharmaceuticals, Inc. (the "Company") received an approval letter ("Approval Letter") from the U.S. Food and Drug Administration ("FDA") to its prior approval supplement ("PAS") in response to FDA's review of the revised Drug Master File ("DMF") of R-Tech Ueno, Ltd. ("R-Tech"). The Approval Letter provides for the addition of Nitto Medic, 1-14-1 Yasuuchi, Yatsuo-machi, Toyama-shi, Toyama, Japan as a new production site for Rescula (unoprostone isopropyl ophthalmic solution) 0.15%. The Company has adequate supply of RESCULA to be able to supply the US market into the first quarter of 2015.

The information in this Item 8.01 to this Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

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