BioCentury | Apr 14, 2017
Clinical News

Natesto regulatory update

Hyundai submitted an NDA to South Korea’s Ministry of Food and Drug Safety (MFDS) for Natesto to treat low testosterone. Hyundai has exclusive, South Korean rights to the bioadhesive intranasal gel formulation of testosterone from...
BioCentury | Feb 9, 2015
Clinical News

Natesto regulatory update

Trimel submitted an NDS to Health Canada for Natesto testosterone nasal gel as replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone. The bioadhesive intranasal gel formulation of testosterone...
BioCentury | Aug 4, 2014
Clinical News

Tefina: Phase II data

...in 253 pre- and post-menopausal women experiencing acquired female orgasmic disorder showed that 0.6 mg Tefina...
...was 2 for the Tefina group vs. 0 for placebo. On secondary endpoints, 0.6 mg Tefina...
...did not disclose a time frame. Trimel Pharmaceuticals Corp. (TSX:TRL), Mississauga, Ontario Product: Tefina (formerly TBS-2...
BioCentury | Jun 2, 2014
Clinical News

Natesto regulatory update

FDA approved an NDA from Trimel for Natesto to treat testosterone deficiency. The company said it has not yet established a launch date or pricing for the product. In January, FDA extended by 3 months...
BioCentury | Jan 20, 2014
Clinical News

CompleoTRT regulatory update

FDA extended by 3 months the PDUFA date for an NDA for CompleoTRT to treat testosterone deficiency in men. The new PDUFA date is May 28; it was Feb. 28. Trimel said the agency needs...
BioCentury | Jan 20, 2014
Clinical News

Tefina: Completed Phase II enrollment

...high-dose Tefina in about 240 women. Trimel Pharmaceuticals Corp. (TSX:TRL), Mississauga, Ontario Product: Tefina (formerly TBS-2...
BioCentury | Jan 6, 2014
Clinical News

CompleoTRT regulatory update

On Dec. 19, 2013, Trimel said that after a discussion with FDA, it will amend its proposed label for CompleoTRT to treat testosterone deficiency to reflect thrice-daily dosing. The company said it made the decision...
BioCentury | Nov 4, 2013
Clinical News

CompleoTRT regulatory update

Trimel said FDA requested additional information as part of the agency's review of an NDA from the company for CompleoTRT to treat testosterone deficiency. The company said FDA has not yet advised the company of...
BioCentury | Jul 15, 2013
Clinical News

CompleoTRT regulatory update

Trimel said FDA accepted for review an NDA for CompleoTRT to treat testosterone deficiency in men. The PDUFA date is Feb. 28, 2014. The product is a bioadhesive intranasal gel formulation of testosterone. Trimel Pharmaceuticals...
BioCentury | May 6, 2013
Clinical News

CompleoTRT regulatory update

Trimel submitted an NDA to FDA for CompleoTRT to treat testosterone deficiency in men. The product is a bioadhesive intranasal gel formulation of testosterone. Trimel Pharmaceuticals Corp. (TSX:TRL), Mississauga, Ontario Product: CompleoTRT (formerly TBS-1 ) Business:...
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