NDC Package 65862-887-92 Kalliga

6 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (65862-887-28) / 1 KIT in 1 BLISTER PACK

65862-887

Desogestrel And Ethinyl Estradiol

KalligaTM tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.In a clinical trial with KalligaTM, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly.Table 1: 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 Year*Method(1)Typical Use †(2)Perfect Use‡(3) (4)Chance#85 85  SpermicidesÞ26 6 40 Periodic abstinence 25  63  Calendar  9  Ovulation Method  3   Sympto-Thermalß 2   Post-Ovulation  1  Withdrawal19 4  Capà    Parous Women 40 26 42  Nulliparous Women20956Sponge    Parous Women402042 Nulliparous Women20956Diaphragmà20656Condomè    Female (Reality®)21556 Male14361Pill5 71 Progestin Only 0.5  Combined 0.1 IUD    Progesterone T21.581 Copper T380A0.80.678 LNg 200.10.181Depo-Provera0.30.370Norplant® and Norplant-2®0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.1100Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.§Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.¶Source: Trussell J. Contraceptive efficacy. 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.*           Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one 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 treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of 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 yellow pills).¶     However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.#     The percents 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.Þ    Foams, creams, gels, vaginal suppositories, and vaginal film.ß    Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.à    With spermicidal cream or jelly.è    Without spermicides.KalligaTM has not been studied for and is not indicated for use in emergency contraception.

65862088792

Human Prescription Drug

Aurobindo Pharma Limited

Kit - A packaged collection of related material.

No

ANDA207081

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

05-17-2017

12-31-2024

N