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Sprout Pharmaceuticals Inc.

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

Latest From Sprout Pharmaceuticals Inc.

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

US FDA’s Higher Bar For Postmarketing Pregnancy Studies Shown By AMAG’s Vyleesi, Sprout’s Addyi

Agency’s postmarketing requirements to assess Vyleesi risk in pregnant and lactating women highlight the changes catalyzed by draft guidances issued in April.

Drug Approval Standards Drug Safety

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

Keeping Track: FDA OKs AMAG's Vyleesi, But Bronchitol And Quizartinib Draw CRLs

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

Approvals Drug Review
See All

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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