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Sprout Pharmaceuticals Inc.

Division of Bausch Health Companies Inc.
http://www.addyi.com/

Latest From Sprout Pharmaceuticals Inc.

Sprout’s Addyi Loses Blanket Alcohol Contraindication And REMS Distribution Restrictions

US FDA’s approval of labeling supplements for the hypoactive sexual desire disorder drug followed Sprout’s appeal of a safety-related change order; boxed warning now states patients should wait at least two hours after drinking alcohol before taking flibanserin.

Drug Safety Post Market Regulation & Studies

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

CDER Midyear Report: Sponsors Struggle With Drop In Novel Approval Rate

CDER has approved only 13 novel products in the first half of 2019 while issuing at least seven such CRLs during that timeframe. The sparse approval landscape more so resembles that of 2016 compared with the banner years of 2017 and 2018.

Approvals Complete Response Letters
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Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Gynecological, Urological
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Bausch Health Companies Inc.
  • Senior Management
  • Cindy Whitehead, CEO
    Matthew Petzold, CFO
    Rich Franco, EVP, Commercial Strategy
  • Contact Info
  • Sprout Pharmaceuticals Inc.
    Phone: (919) 882-0850
    4208 Six Forks Rd.
    Ste. 1010
    Raleigh, NC 27609
    USA
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