The FDA had already extended the review period for Lybrel before. The drug's maker, Wyeth Pharmaceuticals, tells The Associated Press it was hoping the FDA would approve the drug on Tuesday.
However, the FDA requested an additional delay because it wanted more data on the contraceptive's shelf life, pregnancy rates and trial dropout rates.
If the pill is used 365 days a year, it will stop women from menstruating completely.
Clinical trial data shows the contraceptive was 98 percent effective in preventing pregnancy.
Wyeth tells the AP that some users reported side effects, including bleeding or spotting.
