Lybrel, a non-cyclic combination oral contraceptive, has failed to get the approval by the Food and Drug administration (FDA). The drug is made in Guyama plant at Wyeth, Puerto Rico. FDA was very much concern about the quality control level at the plant.
FDA sent an approvable letter to the drug manufacturer that confirms the suspension of the drug approval. Wyeth says that they should submit more data and medicinal details of the drug to FDA.
The scientists of Wyeth will submit the manufacturing processes and analyses of Lybrel to the FDA now. The scientists will review the US Pearl Index, a calculation of pregnancy rates, bleeding patterns of participants during a fresh study.
Read