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Reclast FDA Approval History

FDA Approved: Yes (First approved April 16, 2007)
Brand name: Reclast
Generic name: zoledronic acid
Dosage form: Injection
Previous Name: Aclasta
Company: Novartis
Treatment for: Paget's Disease, Prevention of Osteoporosis, Prevention of Fractures

Reclast (zoledronic acid) is a bisphosphonate indicated for the treatment for Paget's disease, postmenopausal osteoporosis and prevention of fractures.

Development timeline for Reclast

Jun  1, 2009Approval FDA Approves Reclast to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing
Jun  5, 2008Approval FDA broadens US indication for once-yearly Reclast as only osteoporosis treatment approved for prevention of fractures after a hip fracture
Aug 20, 2007Approval Reclast Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
Apr 17, 2007Approval Reclast Receives US Approval as a Highly Effective Treatment for Patients with Paget's Disease of the Bone
Feb 24, 2006Novartis receives approvable letter" from the FDA for zoledronic acid 5 mg in the treatment of Paget's disease of the bone"

Further information

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