May 18, 2018 / 11:39 AM / 3 months ago

BRIEF-Agile Therapeutics Provides Regulatory Update On Twirla® (Ag200-15) For The Prevention Of Pregnancy

May 18 (Reuters) - Agile Therapeutics Inc:

* AGILE THERAPEUTICS, INC. PROVIDES REGULATORY UPDATE ON TWIRLA® (AG200-15) FOR THE PREVENTION OF PREGNANCY

* AGILE THERAPEUTICS - ANNOUNCED CONTENT OF OFFICIAL MINUTES FROM TYPE A MEETING WITH U.S. FOOD AND DRUG ADMINISTRATION HELD ON APRIL 16

* AGILE THERAPEUTICS INC - IN CRL, FDA INFORMED COMPANY THAT TWIRLA NDA COULD NOT BE APPROVED

* AGILE THERAPEUTICS - IN OFFICIAL MINUTES, FDA INFORMED CO IT CONTINUES TO HAVE SIGNIFICANT CONCERNS REGARDING ADHESION OF TWIRLA

* AGILE THERAPEUTICS INC - FDA ALSO INFORMED CO IT WOULD NEED TO DEMONSTRATE BIOEQUIVALENCE TO DATA AND INFORMATION FOR ORIGINAL FORMULATION

* AGILE - FDA SAID CO NEEDS TO ADDRESS TWIRLA ADHESION PROPERTIES BY REFORMULATING TRANSDERMAL SYSTEM, CONDUCT FORMAL ADHESION STUDY WITH NEW FORMULATION

* AGILE THERAPEUTICS - FDA SAID AFTER CO SATISFIES QUESTIONS ON ADHESION, ADEQUATELY BRIDGES TO FINDINGS IN SECURE PHASE 3 TRIAL, IT ANTICIPATES DISCUSSING SAFETY & EFFICACY OF TWIRLA

* AGILE THERAPEUTICS INC - TO EXTENT THAT CO REFORMULATES TWIRLA, IT MAY CREATE NEED FOR ADDITIONAL MANUFACTURING WORK AND REVIEW BY FDA

* AGILE THERAPEUTICS INC - WHILE CO WILL CONTINUE TO EVALUATE ALL OPTIONS ON NEXT STEPS, EXPECT CO WILL PURSUE FORMAL DISPUTE RESOLUTION. Source text for Eikon: Further company coverage: (Reuters.Briefs@thomsonreuters.com)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below