FDA Approves TLANDO® (testosterone undecanoate), an Oral Treatment for Testosterone Replacement Therapy by Antares Pharma, Inc., developed by Lipocine Inc.


MIAMI, April 25, 2022 /PRNewswire/ -- Brand Institute is proud to announce working with Lipocine Inc. in developing the brand name TLANDO®, approved by the Food and Drug Administration (FDA) on March 28, 2022.  TLANDO® is an oral treatment for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone in adult males.

TLANDO® was developed by Lipocine Inc., a clinical-stage biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders. Lipocine has granted Antares Pharma an exclusive license to commercialize TLANDO® in the U.S.

"The entire Brand Institute and Drug Safety Institute Team congratulates Antares Pharma and Lipocine on the FDA approval of TLANDO," said Brand Institute's Chairman and C.E.O., James L. Dettore.

About Brand Institute and our wholly owned regulatory subsidiary, Drug Safety Institute
Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 3,800 marketed healthcare brand names, 1,200 USAN/INN nonproprietary names for 1,100 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers. Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines while with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling.

James Dettore
Chairman & C.E.O.


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SOURCE Brand Institute, Inc.


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