Injectable Boniva drug in short supply - US FDA

Thu Jun 7, 2012 10:13pm IST

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* Company did not accurately forecast demand-FDA

* Genentech to resume shipments in mid to late June

WASHINGTON, June 7 (Reuters) - Patients who want an injectable form of Roche Holding AG's bone-strengthening drug Boniva may not be able to get it in the next few weeks 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, 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 injectable form of Boniva, known generically as ibandronate, is meant for women who want to prevent or treat osteoporosis after menopause but have trouble with oral pills. It is the only osteoporosis drug in the class known as bisphosphonates that is available as an injection, Genentech said.

Unlike Boniva tablets, which people take once a month, Boniva injections are given once every three months.

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.

The FDA last year considered putting time limits on using bisphosphonate drugs due to concerns about unusual fractures linked to the medicines.

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