Lybrel receives an FDA approvable letter
New Jersey, USA-based Wyeth says that the Food and Drug Administration has issued an approval letter in relation to its oral contraceptive Lybrel (90mcg levonorgestrel/20mcg ethinyl estradiol tablets). In response, the firm said that it will submit additional stability data regarding the drug's manufacture, as well as carrying out additional analysis of clinical data as requested by the agency.
The company also reported the FDA's intention to hold a public meeting of contraceptive experts to discuss bleeding patterns and discontinuation rates observed during studies of the drug, as well as the product's US Pearl Index (rate of pregnancy among trial subjects) score.
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