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Injectable Boniva in Short Supply, FDA Says


WASHINGTON (Reuters) Jun 07 - Clinicians seeking to replenish their supply of injectable ibandronate (Boniva) in the next few weeks may be out of luck because the company did not accurately forecast demand, federal officials said.
A mismatch between company forecasts and actual demand is one of the many reasons medicines can go into shortage, especially when there is only one company making them.
The number of cancer, anesthetic and other drugs in short supply in the United States hit a record high last year with 250 medicines, largely due to manufacturing problems.
The Boniva shortage does not affect the more widely used oral version of the drug which became available generically earlier this year.
Genentech, the Roche unit that makes Boniva, used to prevent and treat osteoporosis, could not immediately say why demand forecasts for injectable Boniva were not accurate.
"Patient safety is of the utmost importance to Genentech, and we are working as fast as we can to address the temporary stock out of Boniva injection," said Christopher Vancheri, Genentech spokesman. He said the company expects to resume shipments of the single-use syringes in mid to late June.
The U.S. Food and Drug Administration announced the shortage of Boniva vials on its website late on Wednesday.
At least five companies recently got FDA permission to sell generic versions of Boniva tablets, including Mylan Pharmaceuticals Inc, Watson Pharmaceuticals Inc and Indian drugmaker Dr Reddy's Laboratories.
An estimated 10 million Americans over the age of 50 have osteoporosis, and another 34 million have low bone mass, according to the National Osteoporosis Foundation.

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