FDA REQUESTS ADDITIONAL DATA ON MENTOR'S URETHRIN
FDA REQUESTS ADDITIONAL DATA ON MENTOR'S URETHRIN SANTA BARBARA, Calif., Nov. 13 /PRNewswire/ -- Mentor Corp.
(NASDAQ: MNTR) announced today that the U.S. Food and Drug Administration (FDA) has issued a letter stating that the company must submit additional clinical data on Urethrin before the product can be approved for marketing. Urethrin is Mentor's injectable implant for the treatment of urinary incontinence.
In previous communications the FDA had indicated that it would approve Urethrin subject to certain requirements, primarily related to labelling. The latest letter imposes new conditions which represent a departure from the FDA's previous position. "We are disappointed that the FDA has yet again changed its mind," said Christopher J. Conway, chairman and chief executive officer of Mentor Corp., "but we are no longer surprised at anything the FDA does. Under the present administration the FDA's actions have been arbitrary and unpredictable, and it has become virtually impossible to bring a new medical product to the public. "Urethrin has been undergoing FDA review since 1986," Conway said. "We had been hoping to get final approval some time next year, but this new request means approval is unlikely for the next two years. "We were not counting on Urethrin approval in the near future," added Conway. "So the company's performance over the next year will not be affected by this additional delay." Mentor Corp. produces medical and surgical devices for the specialties of urology, plastic surgery and ophthalmology. -0- 11/13/92 /CONTACT: Christopher J. Conway of Mentor Corp., 805-681-6000/ (MNTR) CO: Mentor Corp. ST: California IN: MTC SU:
LS-KJ -- LA034 -- 0927 11/13/92 17:32 EST
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|Date:||Nov 13, 1992|
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