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HUNTSVILLE, Ala. — Qualitest Pharmaceuticals has received approval from the Food and Drug Administration for Myzilra tablets, an oral contraceptive.
The company said Monday that the FDA approved Myzilra tablets (levonorgestrel and ethinyl estradiol) 0.05 mg/0.03 mg, 0.075 mg/0.04 mg, 0.125 mg/0.03 mg in a 28-day triphasic regimen.
Total sales for Myzilra tablets in the United States for the 12 months ended Sept. 30 were approximately $34.4 million, according to IMS Health data cited by Qualitest.