FDA APPROVES BONIVA INJECTION
The FDA has approved Boniva (ibandronate sodium) injection, the first intravenous
(IV) medication for the treatment of postmenopausal osteoporosis, Roche and
GlaxoSmithKline have announced. Boniva injection, the first quarterly medication
for the treatment of postmenopausal osteoporosis, is a member of the bisphosphonate
class, which is the most frequently prescribed medicine for osteoporosis. It
is administered once every three months.
Boniva, administered as a 15-to-30-second IV injection, provides an alternative for patients who have difficulty with oral bisphosphonate dosing requirements, including an inability to sit upright for 30 to 60 minutes and/or swallow a pill. The approval was based on results of the DIVA study (Dosing IntraVenous Administration), a clinical trial in 1,358 women with postmenopausal osteoporosis. Boniva will be available this year.