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news.Solvay Pharmaceuticals has submitted a supplemental new drug application for testosterone product AndroGel 1% to the FDA for treatment in males aged between 13-17 years old with primary or secondary hypogonadism.
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The US-based subsidiary of Solvay Group is also seeking an additional indication for AndroGel in the treatment of constitutional delay in growth and puberty (CDGP) in male adolescents.
Solvay intends to market the product under the trade name AndroGel PD for these two indications. As part of the application for new indications, the company has requested a review of the application for pediatric exclusivity designation. If granted, this would extend patent protection for AndroGel by six months.
The sNDA submission is based on two studies that evaluated AndroGel in more than 80 male adolescents with hypogonadism and CDGP for up to six months. AndroGel is a once-daily, clear, odorless topical testosterone gel approved by the FDA in 2000 for replacement therapy in men ages 18 and older for conditions associated with a deficiency or absence of endogenous testosterone. It also is the most prescribed form of testosterone therapy in the US, according to the company.
“AndroGel provides an easy alternative to deep muscle injections of testosterone for teenage boys,” said Laurence Downey, president and CEO of Solvay Pharmaceuticals. “We believe that doctors and teenage boys who are waiting for convenient testosterone treatment will regard AndroGel as an alternative to existing therapies.”