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Generic Plan B Pill for Women 17 and Younger
The FDA has approved the first generic version of the emergency contraceptive Plan B (levonorgestrel). It will be available by prescription only for women aged 17 and younger.
Plan B -- the brand-name drug -- is already available without a prescription to women aged 18 and older. In April, a federal judge ordered the FDA to lower the age limit for Plan B to age 17, and the FDA said it would not appeal that ruling, but that Plan B's maker, the drug company Duramed Pharmaceuticals, Inc. -- would need to file an application first.
But the new generic levonorgestrel product requires a prescription, and it's specifically approved only for women aged 17 and younger.
A woman aged 18 and older could get a prescription for the generic product, but that would be an "off-label" use, because the generic product specifies the age range of the patients for whom it's approved.
Why not just make the generic product available without a prescription?
Because Duramed Pharmaceuticals has a patent on Plan B's nonprescription sales until Aug. 24, 2009. The new generic product is made by a different company, Watson Laboratories Inc., and even after Duramed's patent expires, the generic product won't automatically become available without a prescription -- Watson Laboratories would have to seek FDA approval for that. The FDA won't say whether such an application has been filed.
As for brand-name Plan B, it's a nonprescription drug now, and is no longer approved as a prescription drug for women 18 years and older.
Nonprescription drugs are often called "over-the-counter" drugs, but Plan B isn't out on store shelves; it's stocked behind pharmacy counters.
There is no age limit on how young is too young for the new generic, prescription-only levonorgestrel product. But a doctor would have to prescribe it; young women or girls can't get it otherwise.
Levonorgestrel can prevent pregnancy after unprotected intercourse or a known or suspected contraceptive failure. "It is not effective in terminating an existing pregnancy and does not protect against sexually transmitted diseases, including HIV infection," states an FDA news release.
Plan B -- the brand-name drug -- is already available without a prescription to women aged 18 and older. In April, a federal judge ordered the FDA to lower the age limit for Plan B to age 17, and the FDA said it would not appeal that ruling, but that Plan B's maker, the drug company Duramed Pharmaceuticals, Inc. -- would need to file an application first.
But the new generic levonorgestrel product requires a prescription, and it's specifically approved only for women aged 17 and younger.
A woman aged 18 and older could get a prescription for the generic product, but that would be an "off-label" use, because the generic product specifies the age range of the patients for whom it's approved.
Why not just make the generic product available without a prescription?
Because Duramed Pharmaceuticals has a patent on Plan B's nonprescription sales until Aug. 24, 2009. The new generic product is made by a different company, Watson Laboratories Inc., and even after Duramed's patent expires, the generic product won't automatically become available without a prescription -- Watson Laboratories would have to seek FDA approval for that. The FDA won't say whether such an application has been filed.
As for brand-name Plan B, it's a nonprescription drug now, and is no longer approved as a prescription drug for women 18 years and older.
Nonprescription drugs are often called "over-the-counter" drugs, but Plan B isn't out on store shelves; it's stocked behind pharmacy counters.
There is no age limit on how young is too young for the new generic, prescription-only levonorgestrel product. But a doctor would have to prescribe it; young women or girls can't get it otherwise.
Levonorgestrel can prevent pregnancy after unprotected intercourse or a known or suspected contraceptive failure. "It is not effective in terminating an existing pregnancy and does not protect against sexually transmitted diseases, including HIV infection," states an FDA news release.
3 Comments:
Ok. So im 25 went and got the plan b, did not see that it said Only 17 and younger. i took both pills. My question is will it still work on me? i took it with in the first 24 hrs as well?
I would think so. The pills are made of pretty much the same things. I also took the pill about a month ago but mine gave me some sides affects and i think i still have some.
17 and under is just for the prescription. 17 and older can get it over the counter. Thats what that means!!!
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