NDC Package 0378-7303-53 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate

0378-7303

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate

Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months.Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.Table 2. Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.Emergency Contraceptives Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.èLactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. ðSource: Trussell J, The Essentials of Contraception. In Hatcher RA, Trussell J, Stewart F, Cates W, Stweart GK, Kowel D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.% of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One Year‡Method(1)Typical Use*(2)Perfect Use†(3)(4)Chance§8585Spermicides¶26640Periodic Abstinence2563   Calendar9   Ovulation Method3   Symptothermal#Þ2   Post-ovulation1Capß   Parous Women402642   Nulliparous Women20956Sponge   Parous Women402042   Nulliparous Women20956Diaphragmß20656Withdrawal194Condomà   Female (Reality®)21556   Male14361Pill571   Progestin only0.5   Combined0.1IUD   Progesterone T2.01.581   Copper T380A0.80.678   LNG 200.10.181Depo-Provera®0.30.370Norplant® and   Norplant-2®0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100 ‡ Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. * Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. † Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. § The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.¶ Foams, creams, gels, vaginal suppositories, and vaginal film. #Þ Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.ß With spermicidal cream or jelly.à Without spermicides. è The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of combined oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). ð However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied.Table 3. Acne Vulgaris Indication Pooled Data 376-403 and 376-404 Observed Means at Six Months and at Baseline*Intent To Treat Population Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate TabletsN=296PlaceboN=295Difference in CountsBetween Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets and Placebo at Six Months (95% CI) †Number of LesionsCounts% reductionCounts% reductionINFLAMMATORY LESIONS Baseline Mean 2929Six Month Mean1452%1741%3 (±2)NON-INFLAMMATORY LESIONSBaseline Mean 4443Six Month Mean2738%3225%5 (±3.5)TOTAL LESIONSBaseline Mean 7472Six Month Mean4243%4932%7 (±5)*Numbers rounded to nearest integer†Limits for 95% Confidence Interval; not adjusted for baseline differencesNorethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.Figure 2. Mean Percent Reduction in Total Lesion Counts From Baseline to Each 28-Day Cycle and Mean Total Lesion Counts at Each Cycle Following Administration of Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and Placebo (Statistically significant differences were not found in both studies individually until cycle 6) 

00378730353

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Human Prescription Drug

Mylan Pharmaceuticals Inc.

Kit - A packaged collection of related material.

No

ANDA205069

ANDA - A product marketed under an approved Abbreviated New Drug Application.

07-27-2022

09-30-2025

N