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Fortical Approval History

  • FDA approved: Yes (First approved August 12th, 2005)
  • Brand name: Fortical
  • Generic name: calcitonin
  • Dosage form: Nasal Spray
  • Company: Unigene / Upsher-Smith Laboratories, Inc.
  • Treatment for: Osteoporosis

Fortical is a nasal calcitonin formulation indicated for the treatment of postmenopausal osteoporosis.

Development History and FDA Approval Process for Fortical

Aug 12, 2005Approval Fortical Unigene / Upsher-Smith Laboratories, Inc. - Treatment for Postmenopausal Osteoporosis
Jul 18, 2005Upsher-Smith Laboratories Disappointed in FDA's Decision to Delay Approval of Affordable Osteoporosis Therapy

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