Major Amendment To Oral Testosterone NDA Extends FDA Review

U.S. FDA extends review for Tlando; advisory committee meeting date of January 10, 2018 remains unchanged.

Lipocine Inc., a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for Tlando, the company’s oral testosterone product candidate for the proposed indication of testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) goal date of May 8, 2018.

The FDA extended the action goal date to allow time to review additional data analyses recently submitted as an amendment to the NDA in response to the FDA’s information requests. Upon preliminary review of the amendment by the FDA, the submission of the requested information has been determined to represent a ‘major amendment’ to the NDA resulting in an extension of the PDUFA goal date by three months to provide time for a full review.

The previously scheduled Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) meeting on January 10, 2018 to discuss the NDA for Tlando remains unchanged.

“We believe Tlando addresses a significant unmet medical need for men with hypogonadism and we will continue to work closely with the FDA throughout the review process,” said Dr. Mahesh Patel, chairman, president and chief executive officer of Lipocine.

(Source: Lipocine Inc.)