AMAG Pharmaceuticals

AMAG Pharmaceuticals approved products

Feraheme® (ferumoxytol injection)

• Indication: Intravenous iron replacement therapy for adult patients with iron deficiency anemia (IDA), particularly those with chronic kidney disease (CKD) or who cannot tolerate or respond to oral iron.

• Dose: Two IV infusions of 510 mg each, administered 3 to 8 days apart. Each infusion is given over at least 15 minutes, depending on patient tolerance.

Makena® (hydroxyprogesterone caproate injection; auto-injector)

• Indication: Reduces the risk of preterm birth in women with a singleton pregnancy who have a history of spontaneous singleton preterm birth.

• Dose: 250 mg via intramuscular or subcutaneous (auto-injector) administration once weekly.

Intrarosa® (prasterone vaginal inserts)

• Indication: Treatment of moderate to severe dyspareunia (pain during intercourse) due to vulvar and vaginal atrophy associated with menopause.

• Dose: One vaginal insert routinely administered once daily at bedtime.

Vyleesi® (bremelanotide injection)

• Indication: Treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

• Dose: Self-administered subcutaneous injection as needed, typically within 45 minutes before anticipated sexual activity; maximum one dose per 24 hours and eight doses per month.

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Developmental / Pipeline Candidates

AMAG-423 (digoxin immune fab, ovine)

• Indication in development: Potential treatment for severe preeclampsia in pregnant women.

• Status: Currently in mid- to late-stage clinical trials (Phase 2b/3a); holds Fast Track and Orphan Drug designations.

Ciraparantag

• Indication in development: A reversal agent for patients on novel oral anticoagulants (NOACs) or low molecular weight heparin (LMWH) needing urgent reversal (e.g., in emergency surgery, life-threatening bleeding).

• Status: In development with Fast Track designation; Phase 2 trials planned or underway.