Monday, April 8, 2013

Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions

On Friday last week, the Federal court has ordered the USFDA to make the emergency contraceptive PLAN B (levonorgestrel) available Over-the-Counter (“OTC”) and without age restrictions.  PLAN B is the first emergency contraceptive drug, that was approved by FDA for prescription use in 1999.  The drug product consists of two pills to be taken 12 hours apart in order to prevent pregnancy.  

FDA has 30 days (from Friday, April 5) to approve levonorgestrel as an OTC emergency contraceptive without age or point-of-sale restrictions.  Although the government requested that it be allowed to initiate administrative rulemaking proceedings in the matter, Judge Korman denied the request.


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