Federal Register
Notice: FDA has determined the regulatory review period for Genzyme Corp.’s Ovidrel is 1,787 days for extending a patent which claims the human drug product. Ovidrel is indicated for inducing final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately treated with follicle stimulating hormones as part of an assisted reproductive technology program such as in vitro fertilization and embryo transfer. The product is also indicated for inducing ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. To view this notice, click here.