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Regulatory Focus™ > News Articles > 2019 > 11 > Teva to Re-enter Pediatric Cancer Drug Market After Shortage Concerns

Teva to Re-enter Pediatric Cancer Drug Market After Shortage Concerns

Posted 14 November 2019 | By Zachary Brennan 

Teva to Re-enter Pediatric Cancer Drug Market After Shortage Concerns

Teva Pharmaceuticals said Wednesday afternoon that it will return to manufacturing the pediatric cancer drug vincristine after it previously left the market, which coupled with Pfizer manufacturing issues led to a shortage of the drug.

Pfizer, which controls about 97% of the vincristine market, said in a letter to customers last month that it expects to return to full supplies of the drug by January after an increase in demand for the injectable.

Rep. Anna Eshoo (D-CA) highlighted the recent shortage of vincristine at an Energy & Commerce Committee hearing. But Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said, “My understanding is that Pfizer has supplies and people can call and get vincristine right now.” (Here’s the shortage listing for vincristine on FDA’s website).

Teva, which controlled about 3% of the vincristine market, “notified us properly that they were leaving the market,” but Pfizer “didn’t notify us of their manufacturing issues,” Woodcock added at the hearing, explaining that FDA first heard of Pfizer's shortage from MD Anderson Cancer Center.

Teva said in a statement announcing its re-entering of the market: “We do not take the discontinuance of any product lightly, and we always evaluate the need for our product as thoroughly as possible before deciding to discontinue it (though we are generally not privy to the supply challenges that other manufacturers may be experiencing).”

Manufacturing issues, a lack of incentives to produce less profitable drugs and other logistical and regulatory challenges were all cited as root causes for US drug shortages in a recent FDA report.

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