Tilia Fe Kit
NDC Package 51862-896-06

Ndac And Ee Tablets And Ferrous Fumarate Tablets

Kit - A packaged collection of related material.

Tilia Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months.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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year3 Method Typical Use1 Perfect Use2 (1) (2) (3) (4) Chance4 85 85 Spermicides5 26 6 40 Periodic Abstinence 25 63 Calendar 9 Ovulation Method 3 Symptothermal6 2 Post-ovulation 1 Cap7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm7 20 6 56 Withdrawal 19 4 Condom8 Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera® 0.3 0.3 70 Norplant® and Norplant-2® 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Emergency Contraceptives Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%9. Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10 Source: Trussell J, The Essentials of Contraception. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.1 Among typical couples who initiate use of a method (not necessarily for the first time), thepercentage who experience an accidental pregnancy during the first year if they do not stop usefor any other reason.2 Among couples who initiate use of a method (not necessarily for the first time) and who use itperfectly (both consistently and correctly), the percentage who experience an accidentalpregnancy during the first year if they do not stop use for any other reason.3 Among couples attempting to avoid pregnancy, the percentage who continue to use a methodfor 1 year.4 The percentages becoming pregnant in columns (2) and (3) are based on data from populationswhere contraception is not used and from women who cease using contraception in order tobecome pregnant. Among such populations, about 89% become pregnant within one year. Thisestimate was lowered slightly (to 85%) to represent the percent who would become pregnantwithin one year among women now relying on reversible methods of contraception if theyabandoned contraception altogether.5 Foams, creams, gels, vaginal suppositories, and vaginal film.6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basalbody temperature in the post-ovulatory phases.7 With spermicidal cream or jelly.8 Without spermicides.9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a seconddose 12 hours after the first dose. The Food and Drug Administration has declared the followingbrands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 lightorangepills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellowpills).10 However, to maintain effective protection against pregnancy, another method of contraceptionmust be used as soon as menstruation resumes, the frequency or duration of breastfeeds isreduced, bottle feeds are introduced, or the baby reaches 6 months of age.Norethindrone acetate and ethinyl estradiol 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 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 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 N = 296 Placebo N = 295 Difference in Counts Between Norethindrone acetate and ethinyl estradiol tablets and Placebo at Six Months (95% CI)† Number of Lesions Counts % reduction Counts % reduction INFLAMMATORY LESIONS Baseline Mean 29 29 Six Month Mean 14 52% 17 41% 33  ±2   NON-INFLAMMATORY LESIONS Baseline Mean 44 43 Six Month Mean 27 38% 32 25% 5  ±3.5   TOTAL LESIONS Baseline Mean 74 72 Six Month Mean 42 43% 49 32% 7  ±5  *Numbers rounded to nearest integer† Limits for 95% Confidence Interval; not adjusted for baseline differencesNorethindrone acetate and ethinyl estradiol tablet 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.

Mayne Pharma Inc.

Human Prescription Drug

ANDA202962

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

10-15-2020

12-31-2026

N

No