United Health Products, Inc. (OTCPK: UEEC), (UHP) today confirmed it has submitted its response to the Food & Drug Administration's (FDA) most recent questions and comments on the company's Pre-market Approval (PMA) application. At this time there are no outstanding FDA information requests to UHP, however, the FDA reserves the rights under its review process to request additional information at any time.
As previously disclosed, UHP's PMA application is currently in Substantive Review by the FDA. Receipt of a PMA is a condition to the company's ability to market is HemoStyp products for human surgical procedures. There can be no assurance that a PMA will be granted by the FDA.
Investor relations:
Philippe Niemetz
212 344-6464
p.niemetz@panconsultants.com
About United Health Products -- United Health Products develops, manufactures and markets HemoStyp™, a patented Neutralized Oxidized Regenerated Cellulose (NORC) hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and consumer markets, and is focused on gaining approval to access the human surgical market.
For more on United Health Products, Inc. visit: www.unitedhealthproductsinc.com or contact the Company at info@unitedhealthproductsinc.com
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Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from those expressed or implied by such forward-looking statements.
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Original Source: United Health Products Provides Regulatory Update
