May 9, 2018 / 11:05 AM / 6 months ago

BRIEF-Lipocine Receives Complete Response Letter For Tlando From U.S. FDA

May 9 (Reuters) - Lipocine Inc:

* LIPOCINE RECEIVES COMPLETE RESPONSE LETTER FOR TLANDO FROM U.S. FOOD AND DRUG ADMINISTRATION

* LIPOCINE - NEXT STEP TO REQUEST MEETING WITH FDA TO FURTHER EVALUATE DEFICIENCIES RAISED, TO AGREE ON PATH FORWARD FOR POTENTIAL APPROVAL OF TLANDO

* LIPOCINE INC - CRL ALSO IDENTIFIED ADDITIONAL COMMENTS THAT ARE NOT CONSIDERED APPROVABILITY ISSUES

* LIPOCINE INC - CRL IDENTIFIED FOUR DEFICIENCIES REGARDING ITS NEW DRUG APPLICATION FOR TLANDO Source text for Eikon: Further company coverage:

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