Data from Pharmawand - Curated by EPG Health - Date added 09 June 2018

AMAG Pharmaceuticals, Inc. announced that the FDA has accepted its New Drug Application (NDA) for bremelanotide, a first-in-class melanocortin 4 receptor agonist designed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the bremelanotide NDA is March 23, 2019. HSDD is the most common type of female sexual dysfunction, affecting approximately six million premenopausal women in the U.S. HSDD is characterized by persistent low sexual desire (or libido) that is associated with distress, often negatively impacting women’s emotional health, intimate relationships, and overall quality of life.

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

EADV 2018 Highlights

EADV 2018 Highlights

EADV Congress 2018: Bringing you the latest news and insights from 27th EADV Congress, 12-16 September 2018 Paris, France.

Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

+ 1 more

Transplantation

Transplantation

See information on best practice in solid organ transplantation, and expert discussions on related hot topics.

Load more

Related Content