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Palatin Technologies Inc.

www.palatin.com

Latest From Palatin Technologies Inc.

Vyleesi’s Approval Delayed By Blood Pressure Study Conducted During NDA Review

Although the US FDA first recommended a dedicated ambulatory blood pressure monitoring study in March 2017, AMAG did not move forward with such a trial until late 2018 and only after the agency said the results were needed prior to approving bremelanotide, the Pink Sheet's latest Drug Review Profile finds.

Drug Review Profile Approvals

AMAG’s Vyleesi Review Offers Lessons On Impact Of Patient Input

US FDA accepted change in Phase III endpoint hierarchy for the hypoactive sexual desire disorder drug based on input from a patient-focused drug development meeting and scientific workshop; bremelanotide review documents advise on use of multiple anchor scales to help interpret meaningfulness of changes in clinical outcome assessment scores.

Drug Review Profile Approvals

AMAG Must Build Market For Approved Female Libido Drug To Avoid Addyi’s Fate

AMAG Pharmaceutical’s HSDD drug Vyleesi, has been approved by the FDA. But analysts warn it must build the market in women who may not be aware they have a condition if it is to fare better than Sprout’s Addyi.

Approvals Gynecology & Urology

US FDA Approval Actions To Watch Out For In June

User fee goal date calendar for June includes AMAG’s female sexual dysfunction drug Vyleesi, new indications for Sanofi/Regeneron’s Dupixent in rhinosinusitis and Merck’s Zerbaxa in nosocomial pneumonia.

Drug Review Drug Approval Standards
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Company Information

  • Industry
  • Biotechnology
    • Large Molecule
  • Pharmaceuticals
  • Therapeutic Areas
  • Cardiovascular
  • Dermatology
  • Gynecological, Urological
  • Inflammation
  • Metabolic Disorders
  • Respiratory, Pulmonary
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Palatin Technologies Inc.
  • Senior Management
  • Carl Spana, PhD, Pres. & CEO
    Stephen T Wills, EVP, CFO & COO
    Johna D Lucas, MD, CMO
    Libby Keating, VP, Commercial Dev
  • Contact Info
  • Palatin Technologies Inc.
    Phone: (609) 495-2200
    4-B Cedar Brook Dr.
    Cranbury, NJ 08512
    USA
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