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| | FR Doc 03-9065 |
 | | The agency withdrew approval of NDA 10-597 (Tace with Androgen Capsules containing chlorotrianisene and methyltestosterone) and NDA 11-267 (Halodrin Tablets containing fluoxymesterone and ethinyl estradiol) in Federal Register notices of June 25, 1993 (58 FR 34466), and March 2, 1994 (59 FR 9989), respectively. |
 | | With respect to virilization (i.e., hirsutism, acne, deepening of the voice, alopecia, and clitoromegaly), FDA observed that the incidence varied widely in clinical studies and appeared to be dose and duration dependent. |
 | | The 15 menopausal symptoms evaluated were hot flushes, cold sweats, vaginal dryness, cold hands and feet, breast pain or tenderness, numbness and tingling, skin crawls, edema, increased facial or body hair, voice deepening, acne, trouble sleeping, pounding of the heart, dizzy spells, and pressure or tightness in the head or body. |
| www.fda.gov /OHRMS/DOCKETS/98fr/03-9065.html (3154 words) |
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