FDA Completes Wyeth Guayama Inspection But Has Remaining Concerns
This article was originally published in The Pink Sheet Daily
Executive Summary
Wyeth will provide update on the status of products under review at the agency on April 19.
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Wyeth plans to respond in writing to FDA's remaining concerns with its Guayama, Puerto Rico, manufacturing facility by mid-April, the company said. The firm announced April 5 that FDA's inspection of the facility has been completed, although it remains unclear how the timeline will impact the approval of pending products at FDA. "Based on the nature of the inspection observations issued by the FDA, Wyeth is hopeful that it can respond to the remaining concerns and that the agency will be able to determine in the near future that the warning letter issues have been satisfactorily resolved," Wyeth said. The update by Wyeth follows the conclusion of the FDA inspection, which was conducted after the company received a warning letter from the agency in May 2006, citing several concerns (1 (Also see "Wyeth Warning Letter Reflects Continued Difficulties With Hormone Manufacturing" - Pink Sheet, 30 May, 2006.)). In March, the company signaled that the inspection was taking longer than anticipated. Chief Financial Officer Kenneth Martin had assured analysts that the delay would not hold up the ultimate launch of products pending at FDA (2 (Also see "Wyeth Guayama Inspection Will Take Longer Than Anticipated" - Pink Sheet, 1 Mar, 2007.)). Wyeth said it will update investors on the status of its products under FDA review during its first quarter earnings call scheduled for April 19. The firm has several drugs pending at FDA, including two drugs with action dates on April 23, Viviant (basedoxifene) for osteoporosis and the Effexor follow-on Pristiq (desvenlafaxine) for menopausal vasomotor symptoms. Wyeth has already received an "approvable" letter for the serotonin-norepinephrine reuptake inhibitor Pristiq for an earlier NDA for a major depressive disorder indication based on the outstanding issues at Guayama (3 (Also see "Wyeth’s Pristiq Deemed “Approvable” By FDA" - Pink Sheet, 23 Jan, 2007.)). Approval of the kidney cancer drug Torisel - which has an April 5 action date at FDA - will not be held up by the inspection since it is an injectable and is not manufactured at Guayama. Wyeth is also expecting an FDA review decision for the extended-cycle oral contraceptive Lybrel (levonorgestrel/ethinyl estradiol) by June 27. Bifeprunox is also pending at FDA for schizophrenia with an August action date. The Guayama facility separately underwent a current Good Manufacturing Practices inspection by the European Medicines Agency during the week of March 25, Wyeth reported. That inspection was "concluded successfully with no critical or major observations and Wyeth received a positive evaluation of the site's compliance status," the firm said. -Jessica Merrill ([email protected]) |