Prescribe Right
Prescribe Right
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • COVID-19
    • COVID-19 Updates
    • COVID-19 Vaccines
    • COVID-19 Antivirals
    • COVID-19 Monoclonal Antibodies
    • COVID-19 Plasma Products
    • COVID-19 Anti-Inflammatories
    • Remdesivir
    • Ivermectin
  • Contact Us
  • Home
  • About
    • Endorsements
    • Published Articles
    • Consulting
    • Effective Pharmacotherapy
  • Pipeline News
    • Podcast
    • Recent Tweets
  • Pharmaceutical Pipeline Tracker
    • Access Pharmaceutical Pipeline Tracker
    • Pharmaceutical Pipeline Tracker Demo
    • Sample Drug Review
    • Case Studies >
      • Monitoring Drugs With PDUFA Dates
      • Monitoring Drugs By Therapeutic Category
      • Monitoring by Indication
      • Research a Single Drug
    • Sample Searches >
      • Single Drug Report Sample
      • Indication Search Sample
      • Drug Class Search Sample
      • Therapeutic Area Search Sample
      • Company Search Sample
  • COVID-19
    • COVID-19 Updates
    • COVID-19 Vaccines
    • COVID-19 Antivirals
    • COVID-19 Monoclonal Antibodies
    • COVID-19 Plasma Products
    • COVID-19 Anti-Inflammatories
    • Remdesivir
    • Ivermectin
  • Contact Us
Pipeline News and Updates
Picture

June Approval Outlook

5/30/2019

 
Two drugs have PDUFA dates in June. Bremelanotide is a subcutaneous Injection being developed to treat hypoactive sexual desire disorder and celiprolol is a beta-blocker being developed to treat Ehlers-Danlos syndromes.
 
Bremelanotide from AMAG Pharmaceuticals has a PDUFA Date of Jun 23, 2019, after the FDA had delayed review by 3 months. The drug is a Melanocyte-stimulating hormone and administered as a subcutaneous injection.  Bremelanotide is being developed as a treatment of hypoactive sexual desire disorder (HSDD) in women.  AMAG reported increased desire and lowered distress compared to placebo in two phase III 24-week trials with more than 1,200 women with hypoactive sexual desire disorder. The most common adverse effects are nausea, flushing and headache. No interaction between bremelanotide and alcohol has been reported. We have 6 published studies for bremelanotide in our knowledgebase. Click here to subscribe and view all six studies. 
 
Celiprolol from Acer Therapeutics has a PDUFA Date of Jun 25, 2019. The drug is an oral Beta-blocker being developed as a treatment for Ehlers-Danlos syndromes. In a trial of 53 vascular Ehlers-Danlos syndrome patients, 20% of celiprolol treated patients experienced arterial rupture or dissection, after four-years, compared to 50% with placebo in a study conducted by Greater Paris University Hospitals.  Acer performed a retrospective analysis and verified the 2010 study results in 2017. The most common adverse effect reported with celiprolol is fatigue. We have 1 published study for celiprolol in our knowledgebase. Click here to subscribe and view the study.
 
Next week we will review May’s approvals. Click here to review previous weekly updates.
 
By the way, our annual subscription rate means the Pharmaceutical Pipeline Tracker for Hospital Pharmacy teams costs only $2.76 per day!

Comments are closed.
    Stay informed, subscribe to the 
    ​
    Prescribe Right Pharmaceutical Pipeline Tracker
    Latest Tweets from Prescribe Right

    Archives

    January 2023
    December 2022
    October 2022
    September 2022
    August 2022
    July 2022
    June 2022
    May 2022
    April 2022
    March 2022
    February 2022
    January 2022
    December 2021
    November 2021
    October 2021
    September 2021
    August 2021
    July 2021
    June 2021
    May 2021
    April 2021
    March 2021
    February 2021
    January 2021
    December 2020
    November 2020
    October 2020
    September 2020
    August 2020
    July 2020
    June 2020
    May 2020
    April 2020
    March 2020
    February 2020
    January 2020
    December 2019
    November 2019
    October 2019
    September 2019
    August 2019
    July 2019
    June 2019
    May 2019
    April 2019
    March 2019
    February 2019
    January 2019
    December 2018
    November 2018
    October 2018
    September 2018
    August 2018
    June 2018
    May 2018
    April 2018
    March 2018
    February 2018
    January 2018
    December 2017
    November 2017
    October 2017
    September 2017
    August 2017
    August 2015

    RSS Feed

Services

Pharmaceutical Pipeline Tracker​
Consulting

Company

About
Blog
Tweets

Support

Contact
© COPYRIGHT 2015. ALL RIGHTS RESERVED.