December 22, 2017 / 12:40 PM / 2 months ago

BRIEF-Agile Therapeutics Gets Response Letter From FDA For Pregnancy Prevention Drug Twirla

Dec 22 (Reuters) - Agile Therapeutics Inc:

* AGILE THERAPEUTICS, INC. RECEIVES A COMPLETE RESPONSE LETTER FROM THE FDA FOR TWIRLA® (AG200-15) FOR THE PREVENTION OF PREGNANCY

* AGILE THERAPEUTICS - CRL STATES THAT FDA HAS DETERMINED THAT IT CANNOT APPROVE NDA FOR TWIRLA ITS PRESENT FORM

* AGILE THERAPEUTICS INC - CRL IDENTIFIES DEFICIENCIES RELATING TO QUALITY ADHESION TEST METHODS

* AGILE THERAPEUTICS-FDA INDICATED APPLICABLE SECTIONS OF AMENDED NDA SUBMITTED BY CO COULD BE INCORPORATED WHEN RESPONDING TO DEFICIENCIES NOTED IN CRL

* AGILE THERAPEUTICS - CRL ALSO NOTED THAT OBSERVATIONS IDENTIFIED DURING INSPECTION OF A FACILITY OF CORIUM INTERNATIONAL FOR TWIRLA NDA MUST BE RESOLVED

* AGILE THERAPEUTICS INC - CRL DOES NOT IDENTIFY ANY SPECIFIC ISSUES RELATING TO SAFETY OF TWIRLA

* AGILE THERAPEUTICS SAYS CRL RECOMMENDS THAT CO ASSESS IN VIVO ADHESION PROPERTIES DEMONSTRATED IN SECURE CLINICAL TRIAL

* AGILE THERAPEUTICS - CRL “QUESTIONS” THE IN VIVO ADHESION PROPERTIES OF TWIRLA & THEIR POTENTIAL RELATIONSHIP TO SECURE PHASE 3 CLINICAL TRIAL RESULTS

* AGILE THERAPEUTICS INC - “WE ARE EVALUATING THE FDA‘S RESPONSE” Source text for Eikon: Further company coverage:

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