Lipocine Submits New Drug Application to FDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021
SALT LAKE CITY, Aug. 31, 2015 -- Lipocine Inc. (LPCN), a specialty pharmaceutical company, today announced that it has submitted a 505(b)(2) New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone ("hypogonadism").
"Filing of the NDA for LPCN 1021 is a significant achievement for Lipocine and a major milestone toward bringing this potential testosterone replacement therapy option to patients. LPCN 1021 has the potential both to improve the ease of use compared to the available formulations, including topical gels and injections, and to overcome inadvertent testosterone transference risk to children and partners," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. "We look forward to working closely with the FDA during the review process."
- Published: 31 August 2015
- Written by Editor