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Impax Labs looks to market generic cancer pain drug
HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.
Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon's Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can't be controlled by other drugs.
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FDA approves Erwinaze for acute lymphoblastic leukemia
SILVER SPRING, Md. — The Food and Drug Administration has approved a new chemotherapy drug for treating acute lymphoblastic leukemia, the agency said Friday.
The FDA announced the approval of EUSA Pharma's Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with ALL who have developed an allergy to E. coli-derived asparaginase and pegaspargase chemotherapy drugs.