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Lumara Health Inc.

Division of AMAG Pharmaceuticals Inc.

Latest From Lumara Health Inc.

Makena’s Accelerated Approval Will Hang In Balance At US FDA Panel Meeting In October

Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.

Advisory Committees Review Pathway

Makena Might Stay On Market Despite Failed Confirmatory Trial In Pre-Term Birth

Subgroup analyses by AMAG may support ongoing use, but the once-controversial Makena seems unlikely to be pulled from the US market in any event since compounded progesterone is the only alternative therapy.

Gynecology & Urology Drug Approval Standards

AMAG's Makena Fails Confirmatory Pre-Term Birth Study, But May Not Be Pulled From Market

The company will conduct subgroup analyses to support ongoing use, but analysts believe Makena is unlikely to be pulled from the market when compounded progesterone is the only alternative therapy. Nevertheless, sales already are declining, since generics launched last year.

Drug Approval Standards Clinical Trials

Keeping Track: Vitaros Reenters The Wilderness, Remoxy Gives It A Fourth Try, And Two Novel Approvals

The latest drug development news and highlights from our US FDA Performance Tracker.

Drug Review Regulation
See All

Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
    • Generic Drugs
    • Specialty Pharmaceuticals
  • Therapeutic Areas
  • Gynecological, Urological
  • Alias(es)
  • KV Pharmaceutical Co.
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • AMAG Pharmaceuticals Inc.
  • Senior Management
  • Thomas S McHugh, CFO & Treasurer
    Dan Thompson, VP, Bus. Dev. & Chief Compliance Officer
    Mike Cahill, VP, Sales
    Michael Jozwiakowski, PhD, VP, R&D
  • Contact Info
  • Lumara Health Inc.
    Phone: (314) 645-6600
    16640 Chesterfield Grove Rd.
    Ste. 200
    Chesterfield, MO 63005