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Fortical

Generic name: calcitonin
Treatment for: Osteoporosis

Upsher-Smith Laboratories Disappointed in FDA's Decision to Delay Approval of Affordable Osteoporosis Therapy

MINNEAPOLIS, July 18, 2005 -- Upsher-Smith Laboratories, Inc., a Minnesota-based pharmaceutical company, expressed disappointment today the FDA's decision to delay approval of Fortical calcitonin-salmon (rDNA origin) Nasal Spray, a patented nasal calcitonin product for the treatment of postmenopausal osteoporosis.

"We are enormously saddened by what we feel is the unconscionable delay by the FDA in the approval of Fortical, an important drug therapy for the treatment of osteoporosis," said Mark Robbins, Vice President of Legal and Regulatory Affairs for Upsher-Smith Laboratories. "The Prescription Drug User Fee Act (PDUFA) date for the FDA to issue a final action on the submission of this product was March 16, 2005. When Upsher-Smith launches this new drug therapy, the annual savings to consumers are estimated to be over 100 million dollars. The patients most affected are women 70 years and older, many of whom pay cash for alternative therapies."

Consumers spend over $4 billion annually for the treatment and prevention of osteoporosis. With Fortical, Upsher-Smith will offer the most affordable therapy in this category. "We are anxious to launch this product upon approval and continue our long-standing tradition of offering economic solutions to combat the problem of rising healthcare costs," said Phill Dritsas, Upsher-Smith's Vice President of Marketing and Sales.

Upsher-Smith also announced a restructuring and elimination of positions in response to the FDA delay and market conditions.

"We remain committed to providing valuable therapies at affordable prices," said Mark Evenstad, President of Upsher-Smith. "We feel confident that the changes we have made will place us in the best possible position to ensure a healthy future for our employees and a continued stream of important, affordable therapies for consumers."

For more information, please visit the Upsher-Smith Laboratories, Inc. website.

Posted: July 2005

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Fortical (calcitonin) FDA Approval History

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