ALYACEN 1/35 (ethinyl estradiol) · GLENMARK PHARMS LTD
ALYACEN 7/7/7 and ALYACEN 1/35 Tabletsare indicated for the prevention of pregnancy in women who elect to use this product 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.
Details
- Status
- Prescription
- First Approved
- 2012-01-19
- Routes
- ORAL-28
- Dosage Forms
- TABLET
ALYACEN 1/35 Approval History
What ALYACEN 1/35 Treats
1 FDA approvalsOriginally approved for its first indication in 2012 .
- Other (1)
Other
(1 approval)- • Approved indication (Jan 2012)
ALYACEN 1/35 Boxed Warning
CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including ALYACEN 7/7/7 and ALYACEN 1/35, should not be used by women who are over 35 years of age and smoke. Patients should be counseled that this product does not protect again...
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including ALYACEN 7/7/7 and ALYACEN 1/35, should not be used by women who are over 35 years of age and smoke. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. COMBINED ORAL CONTRACEPTIVES Each of the following products is a combined oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. ALYACEN 7/7/7 Tablets: Each white to off-white tablet contains 0.5 mg of norethindrone, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include colloidal silicon dioxide, anhydrous lactose, lactose monohydrate, magnesium stearate, pregelatinized starch and talc. Each light peach tablet contains 0.75 mg of norethindrone, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include colloidal silicon dioxide, FD&C Yellow No. 6, anhydrous lactose, lactose monohydrate, magnesium stearate, pregelatinized starch and talc. Each peach tablet contains 1 mg of norethindrone, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include colloidal silicon dioxide, FD&C Yellow No. 6, anhydrous lactose, lactose monohydrate, magnesium stearate, pregelatinized starch and talc. Each light green tablet contains only inert ingredients, as follows: D&C Yellow No. 10, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. ALYACEN 1/35 Tablets: Each peach tablet contains 1 mg of norethindrone, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include colloidal silicon dioxide, FD&C Yellow No. 6, anhydrous lactose, lactos
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340190 | CDAK539A12102 2025-521000-22-00, 2025 | Ph 1 | recruiting | A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies |
| NCT07339722 | 27789 J6V-MC-OIAB | Ph 1 | recruiting | A Study of LY4515100 in Healthy Participants |
| NCT06039826 | 18533 J1I-MC-GZBV | Ph 1 | completed | A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALYACEN 1/35 FDA Label Details
Indications & Usage
ALYACEN 7/7/7 and ALYACEN 1/35 Tabletsare indicated for the prevention of pregnancy in women who elect to use this product 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 methods can result in lower failure rates. Table 1: Percentage of Women Experiencing an...
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, com...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.