(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.
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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.