Microgestin 1/20
NDC Package 53002-1549-3

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MICROGESTIN and MICROGESTIN Fe 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 I 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 I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD  % Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use    Lowest    Method   Expected*  Typical**  (No contraception) ......................   (85)  (85)  Oral contraceptives ....................  3     combined ................................   0.1  N/A***     progestin only ........................   0.5  N/A***  Diaphragm with spermicidal cream or jelly ..............................  6  20  Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) ................................   6  26  Vaginal Sponge         nulliparous ..............................   9  20     parous ....................................   20  40  Implant........................................   0.05  0.05  Injection: depot medroxyprogesterone acetate ....................................  0.3  0.3  IUD         progesterone T ........................   1.5  2.0     copper T 380A ........................  0.6  0.8     LNg 20 ....................................   0.1  0.1  Condom without spermicides         female......................................   5  21     male ........................................  3  14  Cervical Cap with spermicidal cream or jelly         nulliparous ..............................   9  20     parous ....................................   26  40  Periodic abstinence (all methods) ..............................  1-9  25  Withdrawal..................................  4  19  Female sterilization......................  0.5  0.5  Male sterilization ........................   0.10  0.15  Adapted from RA Hatcher et al, Reference 7.  *The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.  **This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.  ***N/A - Data not available.

Rpk Pharmaceuticals, Inc.

NDA017876

NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

08-05-2016

12-31-2022

I

No