Plan B One-Step is an emergency contraceptive, a backup methodology of contraception. Emergency contraception is used to cut back the prospect of being pregnant after unprotected intercourse (if different contraception failed or was not used). It isn’t for routine contraceptive use. Plan B One-Step is out there as a nonprescription (over-the-counter or OTC) drug.

A quick historical past of Plan B and Plan B One-Step is as follows:

• On July 28, 1999, FDA authorised a brand new drug utility (NDA) for the unique product, Plan B, for prescription use.
• On August 24, 2006, FDA authorised a supplemental NDA allowing nonprescription availability of Plan B for girls 18 years and older and by prescription for girls 17 years and youthful.
• On July 10, 2009, FDA authorised a supplemental NDA allowing nonprescription availability of Plan B for girls 17 years and older and by prescription for girls 16 years and youthful. Plan B has been discontinued and is not being marketed.
• On July 10, 2009, FDA additionally authorised Plan B One-Step (PBOS) (levonorgestrel) pill, 1.5 mg as a nonprescription product for girls ages 17 and older, and as a prescription-only product for girls ages 16 and beneath. Plan B used a two-dose routine with 0.75 mg of levonorgestrel in every pill to be taken 12 hours aside, whereas PBOS is a single dose pill that comprises 1.5 mg of levonorgestrel.
• On June 20, 2013, FDA authorised PBOS for nonprescription use with out age restrictions.

Q. What’s emergency contraception?
A. Emergency contraception is a technique of stopping being pregnant for use after one other contraceptive fails or after unprotected intercourse. It isn’t for routine contraceptive use. Medication used for this function are referred to as emergency contraceptive drugs, post-coital drugs, or morning-after drugs. Emergency contraceptives include hormonally lively medication.

Q. What’s Plan B One-Step?
A. Plan B One-Step is an emergency contraceptive, a backup methodology to different contraception. It’s within the type of one levonorgestrel capsule (1.5 mg) that’s taken by mouth after unprotected intercourse or contraceptive failure. Levonorgestrel is an artificial hormone utilized in contraception drugs for over 35 years. Plan B One-Step is out there as a nonprescription (over-the-counter or OTC) drug.

Q. How does Plan B One-Step work?
A. Plan B One-Step works earlier than launch of an egg from the ovary. In consequence, Plan B One-Step often stops or delays the discharge of an egg from the ovary. It’s one pill that comprises a better dose of levonorgestrel than contraception drugs and works in the same option to stop being pregnant.

Q. Is Plan B One-Step efficient?
A. Crucial issue affecting how nicely emergency contraception works is how shortly it’s taken after unprotected intercourse or contraceptive failure. Due to this fact, FDA recommends that each one folks utilizing levonorgestrel emergency contraceptives comply with the product instructions precisely and take the product as quickly as attainable inside 72 hours after unprotected intercourse or contraceptive failure.

FDA recommends that buyers discuss to their well being care supplier about emergency contraception prematurely of needing it and perceive the significance of utilizing these merchandise as meant.

Customers and well being care professionals are inspired to report antagonistic reactions from using Plan B One-Step to the FDA’s MedWatch Opposed Occasion Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.

Q. Is Plan B One-Step an abortifacient (inflicting abortion)?
A. No. Plan B One-Step is not going to work if an individual is already pregnant, which means it is not going to have an effect on an current being pregnant. Plan B One-Step prevents being pregnant by appearing on ovulation, which happens nicely earlier than implantation. Proof doesn’t assist that the drug impacts implantation or upkeep of a being pregnant after implantation, subsequently it doesn’t terminate a being pregnant.

Q. Why was the mechanism of motion modified on the Drug Information label and Client Information Leaflet in 2022?
A. The applicant for Plan B One-Step submitted a supplemental new drug utility (labeling complement), as amended, to FDA requesting approval to switch some the mechanism of motion info on the Drug Information label and within the Client Information Leaflet.

Primarily based on cautious consideration of the applicant’s labeling complement, as amended, and extra scientific proof, FDA decided that the labeling for Plan B One-Step ought to be up to date to have the mechanism of motion info be primarily within the Client Information Leaflet. The mechanism of motion within the Client Information Leaflet was up to date so it’s now according to the perfect accessible scientific proof.

Q. Why was the mechanism of motion within the Drug Information label modified to take away wording about fertilization and implantation?
A. In response to the submission of the applicant’s labeling complement, as amended, FDA reviewed presently accessible scientific proof relating to the mechanism of motion for Plan B One-Step. FDA decided the present science helps a conclusion that Plan B One-Step works by inhibiting or delaying ovulation and the midcycle hormonal modifications. The proof additionally helps the conclusion that there is no such thing as a direct impact on fertilization or implantation. FDA additionally decided that essentially the most acceptable placement of mechanism of motion info was primarily within the Client Information Leaflet fairly than within the Drug Information label. Accordingly, FDA eliminated info instantly associated to the mechanism of motion from the “Different Information” part of the Drug Information label and up to date the mechanism of motion info within the Client Information Leaflet to be according to the perfect accessible proof.

The mechanism of motion is never included in nonprescription drug labeling (and, extra particularly, the Drug Information label) and isn’t required underneath FDA’s rules for nonprescription labeling, as this info shouldn’t be wanted for the secure and efficient use of nonprescription medication on the whole. As a result of shoppers could also be fascinated with how Plan B One-Step works, info on the mechanism was stored within the Client Information Leaflet and up to date to be according to the perfect accessible proof. Additionally, each the Drug Information label and Client Information Leaflet retain statements which are according to the mechanism of motion—that the product is not going to work if the girl is already pregnant.

Q. Why was the mechanism of motion within the Client Information Leaflet modified to switch wording about fertilization and implantation?
A. In response to the submission of the applicant’s labeling complement, as amended, FDA reviewed presently accessible scientific proof relating to the mechanism of motion for Plan B One-Step. FDA decided the present science helps a conclusion that Plan B One-Step works by inhibiting or delaying ovulation and the midcycle hormonal modifications. The proof additionally helps the conclusion that there is no such thing as a direct impact on postovulatory processes, corresponding to fertilization or implantation. Accordingly, FDA up to date the mechanism of motion info within the Client Information Leaflet, which included eradicating references to the mechanisms not supported by the perfect accessible scientific proof (that’s, results on fertilization and implantation).

Extra info on FDA’s scientific overview is out there within the decisional memorandum.

Q. Is there details about the mechanism of motion that is still on the Plan B One-Step Drug Information label and the Client Information Leaflet that helps inform shoppers?
A. The Client Information Leaflet contains up to date info on the mechanism of motion to elucidate that Plan B One-Step works earlier than launch of an egg from the ovary. In consequence, Plan B One-Step often stops or delays the discharge of an egg from the ovary.

The Drug Information label and Client Information Leaflet proceed to incorporate info that pertains to when within the reproductive cycle Plan B One-Step works.

Particularly, the Drug Information label retains the next assertion within the “Warnings” part, underneath “Don’t use”: “Don’t use in case you are already pregnant (as a result of it is not going to work).”

Within the Client Information Leaflet, the next statements are retained:

• Underneath the heading “What Plan B One-Step shouldn’t be,” the next assertion will stay: “Plan B One-Step is not going to work in case you are already pregnant and won’t have an effect on an current being pregnant.”
• Underneath the heading “When to not use Plan B One-Step,” the next assertion will stay: “Plan B One-Step shouldn’t be used in case you are already pregnant, as a result of it is not going to work.”

These statements are according to the mechanism of motion described within the Client Information Leaflet and remind the buyer that Plan B One-Step doesn’t work when a girl is already pregnant. Due to this fact, when contemplating when within the reproductive cycle that Plan B One-Step would possibly work, it will likely be clear to the buyer that Plan B One-Step works very early within the reproductive cycle (previous to ovulation).

Q. Are there generics of Plan B One-Step and can the labeling for these generics be up to date to mirror the identical labeling modifications for Plan B One-Step?
A. There are a number of (11) generics of Plan B One-Step with an lively advertising and marketing standing. The generics for Plan B One-Step are authorised for nonprescription use with out age restrictions. A generic drug is required to have the identical labeling because the reference listed drug aside from sure permissible variations, and generic drug holders are anticipated to replace their labeling after FDA has authorised related modifications to the labeling for the corresponding reference listed drug. Accordingly, the generics for Plan B One-Step are anticipated to replace their labeling to mirror the modifications made to the Plan B One-Step labeling by submitting their revised labeling as quickly as attainable.