Ferrous Bisglycinate

1 INDICATIONS AND USAGE Minzoya™ is indicated for use by females of reproductive potential to prevent pregnancy. Minzoya is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy.

12.1 Mechanism of Action COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 ) 2.1 How to Start Minzoya Minzoya is dispensed in a blister card [see How Supplied/Storage and Handling ( 16 )] . Minzoya 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 should be used until after the first 7 consecutive days of administration. 2.2 How to Take Minzoya Minzoya (white to off-white active tablets, and blue placebo tablets) is swallowed whole once a day. Table 1: Instructions for Administration of Minzoya 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. Tablets Color: Levonorgestrel and ethinyl estradiol tablets i.e. active tablets are white to off-white (Day 1 to Day 21). Ferrous bisglycinate tablets i.e. placebo tablets are blue (Day 22 to Day 28). Day 1 Start: Take first white to off-white active tablet on the first day of menses. Take subsequent white to off-white active tablets once daily at the same time each day for a total of 21 days. Take one blue placebo tablet daily for 7 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: Take first active tablet 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 or spermicide) for the first seven days of the patient's first cycle pack of Minzoya. Take subsequent white to off-white tablets once daily at the same time each day for a total of 21 days. Take one blue placebo tablet daily for the following 7 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 Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to Minzoya from another hormonal contraceptive Start on the same day that a new pack of the previous hormonal contraceptive would have started. Switching from another contraceptive method to Minzoya Start Minzoya: 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 nonhormonal contraceptive (such as condoms or spermicide) is needed for the first seven days of the first cycle pack. Implant On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. Starting Minzoya after Abortion or Miscarriage First-trimester: After a first-trimester abortion or miscarriage; Minzoya may be started immediately. An additional method of contraception is not needed if Minzoya is started within 5 days after termination of the pregnancy. If Minzoya is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first cycle pack of Minzoya. Second-trimester: Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Minzoya, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient's first cycle pack of Minzoya. [See Contraindication

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 Common adverse reactions (≥2% of women): headache (14%), metrorrhagia (8%), dysmenorrhea and nausea (7% each), abdominal pain and breast pain (4% each), emotional lability and acne (3% each), and depression, amenorrhea, and vaginal moniliasis (2% each) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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 clinical practice. In a clinical trial with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets, a total of 1477 healthy women of child-bearing potential were enrolled and had 7870 cycles of exposure. Of these, 792 subjects had completed 6 cycles of treatment. The women ranged in age from 17 to 49 years and 87% were Caucasian. Common Adverse Reactions (≥ 2% of women) headache (14%) metrorrhagia (8%) dysmenorrhea (7%) nausea (7%) abdominal pain (4%) breast pain (4%) emotional lability (3%) acne (3%) depression (2%) amenorrhea (2%) vaginal moniliasis (2%) At the time of the report, 133 (9%) subjects had withdrawn from the study due to adverse events. The most frequent were due to headache and metrorrhagia (1% each). Other adverse events occurring in <1% of those who discontinued included amenorrhea, depression, emotional lability, hypertension, acne, menorrhagia, nausea, hypercholesterolemia, weight gain, dysmenorrhea, and flatulence. All other reasons for discontinuation were reported by 3 or fewer subjects. 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 The following additional adverse drug reactions have been reported from worldwide postmarketing experience with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorder : chest pain, dyspnea, palpitations Gastrointestinal Disorders : abdominal pain, nausea, vomiting, diarrhea General Disorders and Administration Site Conditions : chest pain, fatigue, pain, malaise, injection site pain or erythema, feeling abnormal, pyrexia, condition aggravated, asthenia Immune System Disorders : hypersensitivity reactions, including pruritus, rash, urticaria, erythema Injury, Poisoning and Procedural Complications : injury Investigations : weight decreased Musculoskeletal and Connective Ti

5 WARNINGS AND PRECAUTIONS Thrombotic Disorders and Other Vascular Problems : Stop Minzoya if a thrombotic event occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding ( 5.1 ) Liver disease : Discontinue Minzoya if jaundice occurs ( 5.2 ) High Blood Pressure : If used in women with well- controlled hypertension, monitor blood pressure and stop Minzoya if blood pressure rises significantly. ( 5.4 ) Carbohydrate and Lipid Metabolic Effects : Monitor prediabetic and diabetic women taking Minzoya. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia ( 5.6 ) Headache : Evaluate significant change in headaches and discontinue Minzoya if indicated ( 5.7 ) Bleeding Irregularities and Amenorrhea : Evaluate irregular bleeding or amenorrhea ( 5.8 ) 5.1 Thrombotic Disorders and Other Vascular Problems Stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. If feasible, stop levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization. Start levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). The risk increases with age, particularly in women over 35 years of age who smoke. Use COCs with caution in women with cardiovascular disease risk factors. 5.2 Liver Disease Impaired Liver Function Do not use levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Contraindications ( 4 )] . Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets if jaundice develops. Liver Tumors Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets are contraindicated in women with benign and malignant liver tumors [see Contraindications ( 4 )] . Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the risk of liver cancers in COC users is less than one case per million users. 5.3 Risk of Liver Enzyme Elevations with Concomitant

4 CONTRAINDICATIONS Minzoya is contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic disease. 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 )] . • Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions ( 5.10 ) and Use in Specific Populations ( 8.1 )] . • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions ( 5.11 )] . • Hypersensitivity to any of the components. • 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 ) Pregnancy ( 4 ) Breast cancer ( 4 ) Hypersensitivity of any of the components ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )

10 OVERDOSAGE There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.