Lipocine announces filing of NDA for TLANDO in Canada

Lipocine (LPCN) announced that its licensing partner, Verity Pharma, filed a New Drug Submission, NDS, for TLANDO in Canada. TLANDO is the first and only oral testosterone replacement therapy, TRT, option approved by the US Food and Drug Administration, FDA, that does not require dose titration. “Canada represents an attractive market for TLANDO and the filing of the NDS by Verity Pharma represents an important next step in making the product available there,” said Mahesh Patel, CEO of Lipocine. “We believe that, if approved, the introduction of this new and highly differentiated oral TRT option has the potential to drive significant market gains.”