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Qualitest receives FDA approval for Myzilra tablets
HUNTSVILLE, Ala. — The Food and Drug Administration has approved a new oral contraceptive manufactured by Endo subsidiary Qualitest Pharmaceuticals.
The generic drug maker announced approval of Myzilra tablets (levonorgestrel and ethinyl estradiol tablets, USP) in the 0.05-mg/0.03-mg, 0.075-mg/0.04-mg and 0.125-mg/0.03-mg (28-day triphasic regimen) strengths.
U.S. sales for Myzilra tablets totaled approximately $34.4 million for the 12 months ended Sept. 30, according to IMS Health.
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FDA approves Mylan chemoprotective agent
PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for cancer patients.
Mylan announced Monday the approval of dexrazoxane for injection, a generic version of Pharmacia & Upjohn's Zinecard. The drug is a chemoprotective agent, used to protect healthy tissue from cancer drugs.
Various versions of the drug had sales of $3.4 million during the 12-month period ended in September, according to IMS Health.