Aurovela 24 Fe

Product Type: HUMAN PRESCRIPTION DRUG

Route:

Dosage Form:

NDC: 65862-934

Application: ANDA207504

Effective: 20231121

1 INDICATIONS AND USAGE Aurovela 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m 2 has not been evaluated. Aurovela 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. ( 1 ) The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m 2 has not been evaluated. ( 1 , 8.8 )

2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day for 28 days (2.1) Take tablets in the order directed on the blister pack (2.1) Aurovela 24 Fe may be administered without regard to meals (12.3) 2.1 How to Start Aurovela 24 Fe Aurovela 24 Fe is available in a blister pack [see How Supplied/Storage and Handling (16) ]. Aurovela 24 Fe may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception must be used until after the first 7 consecutive days of administration. 2.2 How to Take Aurovela 24 Fe Table 1: Instructions for Administration of Aurovela 24 Fe Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Aurovela 24 Fe active tablets are light yellow to yellow (Day 1 to Day 24). Aurovela 24 Fe inactive tablets are brown (Day 25 to Day 28). Day 1 Start: Take first light yellow to yellow active tablet without regard to meals on the first day of menses. Take subsequent active tablets once daily at the same time each day for a total of 24 days. Take one brown inactive tablet daily for 4 days and at the same time of day that active tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet). Sunday Start: For each 28-day course, take in the following order: Take the light yellow to yellow active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first cycle pack of Aurovela 24 Fe . Take subsequent active tablets once daily at the same time each day for a total of 24 days. Take one brown tablet (ferrous fumarate) daily for the following 4 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 4 days that the brown tablets are taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to Aurovela 24 Fe from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to Aurovela 24 Fe Start Aurovela 24 Fe: ● Transdermal patch ● On the day when next application would have been scheduled. ● Vaginal ring ● On the day when next insertion would have been scheduled. ● Injection ● On the day when next injection would have been scheduled. ● Intrauterine contraceptive ● On the day of removal ● If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. ● Implant ● On the day of removal Starting Aurovela 24 Fe after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Aurovela 24 Fe may be started immediately. An additional method of contraception is not needed if Aurovela 24 Fe is started immediately. If Aurovela 24 Fe is not started within 5 days after termination of the pregnancy, the patient must use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of her first 28-day course of Aurovela 24 Fe. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Aurovela 24 Fe following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first 28-day course of Aurovela 24 Fe [see Contraindications (4) and Warnings and Precautions (5.1) ]. Starting Aurovela 24 Fe after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Aurovela 24 Fe following the instructions in Table 1 for women not currently using hormonal contraception. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Aurovela 24 Fe [see Contraindications (4) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1 and 8.2) ]. 2.3 Missed Tablets Table 2: Instructions for Missed Aurovela 24 Fe Tablets If one active tablet is missed in Weeks 1, 2 or 3 Take the tablet as soon as possible. Take the next pill at the regular time and continue taking one tablet a day until the pack is finished. Back-up contraception is not needed If two consecutive active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing tablets. If two consecutive active tablets are missed in Week 3 or Week 4 or three or more consecutive active tablets are missed at any time Day 1 Start: Throw out the rest of the pack and start a new pack that same day. Sunday Start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing tablets. 2.4 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures must be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking a light yellow to yellow tablet, handle this as a missed tablet [see Dosage and Administration (2.3) ] .

4 CONTRAINDICATIONS Aurovela 24 Fe is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] Have cerebrovascular disease [see Warnings and Precautions (5.1) ] Have coronary artery disease [see Warnings and Precautions (5.1) ] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ] Have uncontrolled hypertension [see Warnings and Precautions (5.4) ] Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6) ] Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7) ] Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7) ] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8) ] Current diagnosis of, or history of, breast cancer, which may be hormone sensitive [see Warnings and Precautions (5.11) ] Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3) ] A high risk of arterial or venous thrombotic diseases ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Breast cancer ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )

Not available.

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.2) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions (greater than or equal to 2%) were: headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, mood changes, bacterial vaginitis, acne, and weight gain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets were evaluated in 743 subjects who participated in an open-label, randomized, active-controlled, multicenter clinical trial of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets for contraception. This trial examined healthy, non-pregnant volunteers aged 18 to 45 years, who were sexually active and had a body mass index of less than or equal to 35 kg/m 2 . Subjects were followed for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. Common Adverse Reactions ( greater than or equal to 2% of all subjects): The most common adverse reactions reported by at least 2% of the 743 women using norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets were the following, in order of decreasing incidence: headache (6.3%), vaginal candidiasis (6.1%), nausea (4.6%), menstrual cramps (4.4%), breast tenderness (3.4%), mood changes (including mood swings (2.2%) and depression (1.1%), bacterial vaginitis (3.1%), acne (2.7%), and weight gain (2.0%). Adverse Reactions Leading to Study Discontinuation : Among the 743 women using norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal bleeding (0.9%), nausea (0.8%), mood changes (0.8%), menstrual cramps (0.4%), increased blood pressure (0.4%), and irregular bleeding (0.4%). 6.2 Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to 10 years of COC use. Figure 1: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. The following adverse reactions have been identified during post approval use of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure. Cardiovascular: chest pain, palpitations, tachycardia, angina pectoris, myocardial infarction. Endocrine disorders: hypothyroidism, hyperthyroidism. Eye disorders: blurred vision, visual impairment, transient blindness, corneal thinning, change in corneal curvature (steepening). GI disorders : nausea, vomiting, abdominal pain, constipation, pancreatitis. Hepatobiliary disorders: cholelithiasis, cholecystitis, hepatic adenoma, hemangioma of liver. Immune system disorders: anaphylactic reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms. Infections: vaginal infection. Metabolism and nutrition disorders : change in weight or appetite (increase or decrease). hypoglycemia, diabetes mellitus, anemia. Musculoskeletal and connective tissue disorders: myalgia. Skin and subcutaneous disorders: alopecia, rash (generalized and allergic), pruritus, skin discoloration, night sweats, swelling face or lips, hirsutism, skin burning sensation, erythema multiforme, erythema nodosum, hemorrhagic eruption. Nervous system disorders: headache, dizziness, migraine, hyperesthesia, paraesthesia, hypoaesthesia, somnolence, loss of consciousness, sensory disturbance. Psychiatric disorders: mood swings, depression, insomnia, anxiety, suicidal ideation, panic attack, changes in libido, bipolar disorder, dissociation, homicidal ideation. Renal and urinary disorders: pollakiuria, dysuria, cystitis-like syndrome. Reproductive system and breast disorders: breast changes (tenderness, pain, enlargement, and secretion), premenstrual syndrome, ovarian cyst, pelvic pain, ovarian cyst ruptured, pelvic fluid collection. Vascular disorders: hot flush, thrombosis/embolism (coronary artery, pulmonary, cerebral, deep vein), migraine, transient ischemic attack, ischemic stroke. Figure 1: Risk of Breast Cancer with Combined Oral Contraceptive Use