Mylan recalling brain tumor drug

mylan
Mylan is recalling a chemo drug used to treat patients newly diagnosed with a glioblastoma brain tumor.

While Mylan’s EpiPen injector for allergic reactions has been the focus of attention lately, the drugmaker also manufactures many other generic products and is now facing an issue with a chemo drug it makes.

Mylan is recalling 4,191 bottles of temozolomide capsules, a generic of Merck & Co.’s chemo drug Temodar. While the quantities are not large, the drug is used to treat patients with newly diagnosed glioblastoma, a form of malignant brain tumor.

Mylan is recalling four dosage forms, all because of customer complaints that some of the bottles had broken or crushed capsules and loose powder in the bottles.  The recall, which began last month, was designated a class II by the FDA Wednesday.

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The drugs were made at Mylan’s plant in Morganstown, West Virginia. That is the same facility that produces the panic disorder drug clonazepam, a generic of Klonopin, that Mylan recalled in the fall. In that case, it issued a voluntary recall of more than 100,000 dose boxes and blister cards of the drug, which was out of specification for an impurity at the 16-month stability testing period.

The recalls come as the drugmaker continues to deal with the fallout over the big price increase it took for its EpiPen. The company has had to absorb a lot of the public fury over the constant price hikes that most drugmaker take on products. Now, as a result of the backlash, Mylan is seeing a number of competitors producing alternatives that many payers are embracing as a cheaper alternative.

Just this month, CVS announced that it now carries an authorized generic of the Adrenaclick, made by Impax, at a cash price of $109.99 for a two-pack, a price that compares to Mylan's generic at $399.99 and its branded EpiPen at $599.99.

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