SILVER SPRING, Md. — The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties.
However, generic labeling will spell out indicated use for women 17 years of age and older considering that Teva has exclusivity on the indication for use for women under the age of 17, FDA decided.
"Restrictive labeling and point of sale restrictions of the type requested by Teva would be inconsistent with how exclusivity for specific populations is generally handled for ANDAs in other contexts," wrote FDA's Kathleen Uhl, acting director of the Office of Generic Drugs at the Center for Drug Evaluation and Research.
"For example, when an innovator’s prescription product is granted exclusivity for a new indication, ANDAs approved for the non-protected conditions of use are not required to bear a statement specifically describing the limitations of the approval or to otherwise restrict the use of the generic drug. Similarly, multiple OTC products lack approval in one or more pediatric populations but no point of sale restrictions apply," she noted. "There is no scientific or regulatory reason to depart from that approach here."