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FDA Issues Approvable Letter for Nasal Calcitonin Osteoporosis Agent
The letter is an official communication from the FDA indicating that the agency is prepared to approve the New Drug Application for Fortical upon the finalization of the labeling and the resolution of specific remaining issues, including the submission of additional information and data. Upon approval, the product will be marketed in the U.S. by Upsher-Smith Laboratories.
"The FDA's action validates our confidence in the quality of Unigene's program and its Fortical product," said Mark Evenstad, President of Upsher-Smith Laboratories. "We are very enthusiastic about Fortical's potential for success in the growing osteoporosis market and we look forward to its launch."
"We are extremely pleased that our product has reached this crucial regulatory milestone," noted Dr. Ronald S. Levy, Executive Vice President of Unigene. "Fortical, which would be our first product approved in the U.S., would offer patients an important new option for the treatment of osteoporosis and we plan to work closely with the agency to ensure that the remaining issues are expeditiously addressed."
Source: Unigene Laboratories, Inc.