(By Balachander) Perrigo Co. (NASDAQ: PRGO) said it has received approval from the U.S. health regulators for its New Drug Application (NDA) for testosterone gel 1%.
The Allegan, Michigan-based developer of over-the-counter (OTC) drugs said its NDA included a bioequivalence study that compared its product to AbbVie's AndroGel 1%.
AndroGel 1% (testosterone gel 1%) is indicated to treat adult males who have low or no testosterone. As measured by Symphony Health, annual sales were roughly $705 million.
"This filing is another example of our investment in new products and continued focus on bringing extended topicals to market," said Perrigo CEO Joseph Papa.
Last week, the company launched clobetasol emulsion propionate foam, 0.05%, the generic equivalent of Olux -E Foam, 0.05%. Clobetasol emulsion propionate foam, 0.05% is indicated to treat moderate to severe dermatosis of the scalp.
On Tuesday, shares gained 1.45% to trade at $107.28. In the past 52-weeks, the stock has been trading between $90.18 and $120.78.