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Binosto Approval History

  • FDA approved: Yes (First approved March 12th, 2012)
  • Brand name: Binosto
  • Generic name: alendronate
  • Dosage form: Effervescent Tablets
  • Company: EffRx Pharmaceuticals SA
  • Treatment for: Osteoporosis

Binosto (alendronate) is a buffered effervescent dosage form of the bisphosphonate drug alendronate sodium administered once weekly for the treatment of osteoporosis.

Development History and FDA Approval Process for Binosto

Mar 15, 2012Approval FDA Approves Binosto, First and Only Effervescent Osteoporosis Treatment in a Buffered Solution
May 11, 2011First EffRx NDA Accepted for Filing by the FDA
Jan 10, 2011EffRx Pharmaceuticals SA Announces Submission of New Drug Application to FDA for Osteoporosis Treatment Targeting Increased Convenience for Patients

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