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Generic Boniva Gets FDA OK
MedPageToday, 2012WASHINGTON -- The FDA has approved the first generic versions of ibandronate (Boniva) tablets for the once-a-month treatment or prevention of osteoporosis after menopause.
Approval was granted to Apotex, Orchid Healthcare, and Mylan Pharmaceuticals to market 150 mg generic ibandronate tablets, the agency said in a statement.
Patients receiving the generics will get a medication guide listing the adverse events related to use of the drug, including esophageal problems, low blood-calcium levels, unusual thigh bone fractures, and other bone, joint, and muscle pain.
Common adverse events include back pain, dyspepsia, extremity pain, diarrhea, headache, and myalgia.
A recent European trial showed that by 21%, yet the USPSTF recommends against routine PSA testing.
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