FDA.reportPublic FDA data

Application 210830

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELURYNGETHINYL ESTRADIOL; ETONOGESTRELRING;VAGINAL0.015MG/24HR;0.12MG/24HRNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210830-001ELURYNGETHINYL ESTRADIOL; ETONOGESTREL0.015MG/24HR;0.12MG/24HRRING / VAGINALAB2019-12-11

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A210830-001AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EluRyngETONOGESTREL AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLCc6c8512d-b258-4be5-8c2f-0f1893f198b92025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

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boxed warning

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including EluRyng, should not be used by women who are over 35 years of age and smoke [see Contraindications (4) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Women over 35 years old who smoke should not use EluRyng. (4) Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. (4)

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS Vascular risks: Stop etonogestrel and ethinyl estradiol vaginal ring use if a thrombotic event occurs. Stop etonogestrel and ethinyl estradiol vaginal ring use at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1) Toxic Shock Syndrome (TSS): If patient exhibits signs or symptoms of TSS, consider the possibility of this diagnosis and initiate appropriate medical evaluation and treatment. (5.2) Liver disease: Discontinue etonogestrel and ethinyl estradiol vaginal ring use if jaundice develops. (5.3) High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop etonogestrel and ethinyl estradiol vaginal ring use if blood pressure rises significantly. (5.5) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. (5.9) Headache: Evaluate significant change in headaches and discontinue etonogestrel and ethinyl estradiol vaginal ring use if indicated. (5.10) Uterine bleeding: Evaluate irregular bleeding or amenorrhea. (5.11) 5.1 Thromboembolic Disorders and Other Vascular Problems Stop etonogestrel and ethinyl estradiol vaginal ring use if an arterial thrombotic or venous thromboembolic event (VTE) occurs. Stop etonogestrel and ethinyl estradiol vaginal ring use if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see Adverse Reactions (6) ]. If feasible, stop etonogestrel and ethinyl estradiol vaginal ring at least four weeks before and through two weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism, and during and following prolonged immobilization. Start etonogestrel and ethinyl estradiol vaginal ring no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. The use of CHCs increases the risk of VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs [see Contraindications (4) ] . Two e...

warnings and cautions table

Epidemiologic Study (Author, Year of Publication) Population Studied Comparator Product(s) Hazard Ratios (HR) (95% CI) TASC (Dinger, 2012) Initiators, including new users, switchers and restarters All COCs available during the course of the study *COCs available excluding DSG- or GSD -containing OCs HR†: 0.8 (0.5 to 1.5) HR†: 0.8 (0.4 to 1.7) FDA-funded Study in Kaiser Permanente and Medicaid databases (Sidney, 2011) First use of a combined hormonal contraceptive (CHC) during the study period COCs available during the course of the study‡LNG/0.03 mg ethinyl estradiol HR§: 1.1 (0.6 to 2.2) HR§: 1.0 (0.5 to 2.0)

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following serious adverse reactions with the use of CHCs 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 (5.3) ] Adverse reactions commonly reported by CHC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions (≥2%) in clinical trials were: vaginitis, headache (including migraine), mood changes (e.g., depression, mood swings, mood altered, depressed mood, affect lability), device-related events (e.g., expulsion/discomfort/foreign body sensation), nausea/vomiting, vaginal discharge, increased weight, vaginal discomfort, breast pain/discomfort/tenderness, dysmenorrhea, abdominal pain, acne, and decreased libido. (6) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. Trials with a duration of 6 to 13 28-day cycles provided safety data. In total, 2,501 women, aged 18 to 41 contributed 24,520 cycles of exposure. Common Adverse Reactions (≥ 2%): vaginitis (13.8%), headache (including migraine) (11.2%), mood changes (e.g., depression, mood swings, mood altered, depressed mood, affect lability) (6.4%), device-related events (e.g., expulsion/discomfort/foreign body sensation) (6.3%), nausea/vomiting (5.9%), vaginal discharge (5.7%), increased weight (4.9%), vaginal discomfort (4.0%), breast pain/discomfort/tenderness (3.8%), dysmenorrhea (3.5%), abdominal pain (3.2%), acne (2.4%), and decreased libido (2.0%). Adverse Reactions (≥ 1%) Leading to Study Discontinuation: 13.0% of the women discontinued from the clinical trials due to an adverse reaction; the most common adverse reactions leading to discontinuation were device-related events (2.7%), mood changes (1.7%), headache (including migraine) (1.5%) and vaginal symptoms (1.2%). Serious Adverse Reactions: deep vein thrombosis [see Warnings and Precautions (5.1) ] , anxiety, chole...

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-469EluRyngEtonogestrel and Ethinyl EstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-469EluRyngEtonogestrel and Ethinyl EstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-469EluRyngEtonogestrel and Ethinyl EstradiolAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73160ORIG2023-01-13
62241ORIG2020-03-23