Ella

Ella is an FDA-registered drug product whose active ingredient is ULIPRISTAL ACETATE. It is labelled by PMI Branded Pharmaceuticals, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 73302-456, application NDA022474, label effective 20260720. It is one of 2 FDA drug label records sharing the active ingredient ULIPRISTAL ACETATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ULIPRISTAL ACETATE are most often described in connection with: ella progesterone, agonist antagonist, emergency contraceptive, prevention pregnancy, following unprotected, intercourse known, failure see. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure [see Dosage and Administration (2.1) ] . Ella is not intended for routine use as a contraceptive. Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Ella is not intended for routine use as a contraceptive. ( 1 )

2 DOSAGE AND ADMINISTRATION • Take one tablet orally as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. Take with or without food. Take at any time during the menstrual cycle. ( 2.1 ) • After ella use, initiate or resume hormonal contraception no sooner than 5 days after the intake of ella and use a reliable barrier method until the next menstrual period. ( 2.2 ) • If vomiting occurs within 3 hours of taking ella , consider repeating the dose. ( 2.3 ) 2.1 Recommended Dosage and Administration • Take one tablet of ella orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. • Take ella with or without food. • Take ella at any time during the menstrual cycle. 2.2 Recommendations Regarding Use with Hormonal Contraception After ella use, initiate or resume hormonal contraception no sooner than 5 days after the intake of ella and use a reliable barrier method until the next menstrual period. For known or suspected failure of hormonal contraception refer to the hormonal contraceptive’s prescribing information for instructions on what to do [see Warnings and Precautions (5.5) , Drug Interactions (7.1) and Clinical Pharmacology (12.2 )] . 2.3 Recommendation in Case of Gastrointestinal Disturbances If vomiting occurs within 3 hours of taking ella , consider repeating the dose.

4 CONTRAINDICATIONS Ella is contraindicated for use in the case of known or suspected pregnancy [see Use in Specific Populations (8.1) ]. • Known or suspected pregnancy ( 4 )

6 ADVERSE REACTIONS The most common adverse reactions (≥ 5%) in the clinical trials were headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%) and dizziness (5%). ( 6 )To report SUSPECTED ADVERSE REACTIONS, contact HRA Pharma America Inc., at 844-994-0329 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 clinical practice. Ella was studied in an open-label multicenter trial (Open-Label Study) and in a comparative, randomized, single-blind, multicenter trial (Single-Blind Comparative Study). In these studies, a total of 2,637 (1,533 + 1,104) women in the 30 mg ulipristal acetate groups were included in the safety analysis. The mean age of women who received ulipristal acetate was 24.5 years and the mean body mass index (BMI) was 25.3. The racial demographics of those enrolled were 67% Caucasian, 20% Black or African American, 2% Asian, and 12% other. The most common adverse reactions (≥ 10%) in the clinical trials for women receiving ella were headache (18% overall), nausea (12% overall) and abdominal and upper abdominal pain (12% overall). Table 1 lists those adverse reactions that were reported in ≥ 5% of subjects in the clinical studies ( 14 ). Table 1: Adverse Reactions in ≥ 5% of Women (%) Receiving a Single Dose of ella (30 mg Ulipristal Acetate) Most Common Adverse Reactions Open-Label Study Single-Blind Comparative Study N = 1,533 N = 1,104 Headache 18 19 Nausea 12 13 Abdominal and upper abdominal pain 15 8 Dysmenorrhea 7 13 Fatigue 6 6 Dizziness 5 5 6.2 Postmarketing Experience Adolescents: the safety profile observed in adolescents aged 17 and younger in studies and post-marketing is similar to the safety profile in adults [see Pediatric Use (8.4) ] . The following adverse reactions have been identified during post-approval use of ella : Skin and Subcutaneous Tissue Disorders: Acne Hypersensitivity reactions, including rash, urticaria, pruritis, and angioedema 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.

FDA lists 2 drug label records with ULIPRISTAL ACETATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Ella used for?
1 INDICATIONS AND USAGE Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure [see Dosage and Administration (2.1) ] . Ella is not intended for routine use as a contraceptive. Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention …

Who makes Ella?
PMI Branded Pharmaceuticals, Inc. is the labeler of record for Ella. 2 FDA label records share the active ingredient ULIPRISTAL ACETATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Ella come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Ella prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ULIPRISTAL ACETATE?
Yes. 2 FDA drug label records list ULIPRISTAL ACETATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Ella been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.