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Generic versions of the emergency contraceptive Plan B One-Step will be allowed on pharmacy shelves, but unlike the brand-name version manufactured by Teva Pharmaceuticals, it will include an age restriction in its label.
The Food and Drug Administration is allowing generic versions of the 1.5 mg levonorgestrel pill to be available for women aged 17 years and older without point-of-sale restrictions, "but with labeling that carves out Teva’s protected uses," according to a Feb. 25 letter written by Dr. Kathleen Uhl, acting director of the FDA’s Office of Generic Drugs, to manufacturers of generic versions of Plan B One Step.
As a result, Plan B One-Step will be allowed on pharmacy shelves with no age restrictions. But purchasing generic versions will require an ID documenting the purchaser is aged 17 years or older.
This action is a result of the FDA’s decision to grant "exclusivity" to Teva to market the product with no age restrictions as a result of the company’s "actual use" study evaluating the ability of females aged 16 years and younger to correctly choose the product. The study was conducted as part of the company’s applications for approval of the one pill, over the counter (OTC) product with no age or point-of-sale restrictions. The FDA has determined that this study can be considered a new clinical study and qualifies for exclusivity, according to the letter. Exclusivity lasts for 3 years.
The FDA decided, however, that Teva did not have exclusivity "for all nonprescription use" of Plan B One-Step, "nor for its location on the retail shelf," the letter said.
In 2013, the FDA approved Plan B One-Step for OTC sale for all ages, with no point-of-sale restrictions, after years of litigation involving the FDA, reproductive rights groups, and the department of Health and Human Services.
Plan B One-Step generally costs about $40-$50, and generic versions generally cost about $35-$45, according to the Emergency Contraception information website, operated by Princeton (N.J.) University’s Office of Population Research and the Association of Reproductive Health Professionals.
Generic versions of the emergency contraceptive Plan B One-Step will be allowed on pharmacy shelves, but unlike the brand-name version manufactured by Teva Pharmaceuticals, it will include an age restriction in its label.
The Food and Drug Administration is allowing generic versions of the 1.5 mg levonorgestrel pill to be available for women aged 17 years and older without point-of-sale restrictions, "but with labeling that carves out Teva’s protected uses," according to a Feb. 25 letter written by Dr. Kathleen Uhl, acting director of the FDA’s Office of Generic Drugs, to manufacturers of generic versions of Plan B One Step.
As a result, Plan B One-Step will be allowed on pharmacy shelves with no age restrictions. But purchasing generic versions will require an ID documenting the purchaser is aged 17 years or older.
This action is a result of the FDA’s decision to grant "exclusivity" to Teva to market the product with no age restrictions as a result of the company’s "actual use" study evaluating the ability of females aged 16 years and younger to correctly choose the product. The study was conducted as part of the company’s applications for approval of the one pill, over the counter (OTC) product with no age or point-of-sale restrictions. The FDA has determined that this study can be considered a new clinical study and qualifies for exclusivity, according to the letter. Exclusivity lasts for 3 years.
The FDA decided, however, that Teva did not have exclusivity "for all nonprescription use" of Plan B One-Step, "nor for its location on the retail shelf," the letter said.
In 2013, the FDA approved Plan B One-Step for OTC sale for all ages, with no point-of-sale restrictions, after years of litigation involving the FDA, reproductive rights groups, and the department of Health and Human Services.
Plan B One-Step generally costs about $40-$50, and generic versions generally cost about $35-$45, according to the Emergency Contraception information website, operated by Princeton (N.J.) University’s Office of Population Research and the Association of Reproductive Health Professionals.
Generic versions of the emergency contraceptive Plan B One-Step will be allowed on pharmacy shelves, but unlike the brand-name version manufactured by Teva Pharmaceuticals, it will include an age restriction in its label.
The Food and Drug Administration is allowing generic versions of the 1.5 mg levonorgestrel pill to be available for women aged 17 years and older without point-of-sale restrictions, "but with labeling that carves out Teva’s protected uses," according to a Feb. 25 letter written by Dr. Kathleen Uhl, acting director of the FDA’s Office of Generic Drugs, to manufacturers of generic versions of Plan B One Step.
As a result, Plan B One-Step will be allowed on pharmacy shelves with no age restrictions. But purchasing generic versions will require an ID documenting the purchaser is aged 17 years or older.
This action is a result of the FDA’s decision to grant "exclusivity" to Teva to market the product with no age restrictions as a result of the company’s "actual use" study evaluating the ability of females aged 16 years and younger to correctly choose the product. The study was conducted as part of the company’s applications for approval of the one pill, over the counter (OTC) product with no age or point-of-sale restrictions. The FDA has determined that this study can be considered a new clinical study and qualifies for exclusivity, according to the letter. Exclusivity lasts for 3 years.
The FDA decided, however, that Teva did not have exclusivity "for all nonprescription use" of Plan B One-Step, "nor for its location on the retail shelf," the letter said.
In 2013, the FDA approved Plan B One-Step for OTC sale for all ages, with no point-of-sale restrictions, after years of litigation involving the FDA, reproductive rights groups, and the department of Health and Human Services.
Plan B One-Step generally costs about $40-$50, and generic versions generally cost about $35-$45, according to the Emergency Contraception information website, operated by Princeton (N.J.) University’s Office of Population Research and the Association of Reproductive Health Professionals.
