FDA Clears Testosterone Gel – Analyst Blog

Recommended by Dr. Michael White, Updated on May 4th, 2015

Recently, Perrigo Company (PRGO) announced that it has gained approval from the US Food and Drug Administration (FDA) pertaining to its New Drug Application (NDA) for testosterone gel 1%. We note that the New Drug Application filed by the company with the US regulatory body included a bioequivalence study comparing testosterone gel 1% with AbbVie Inc.'s (ABBV) AndroGel 1%.

We note that AndroGel 1% (testosterone gel 1%) is marketed for treating males (above 18 years of age) with low or no testosterone in their body. The annual sales of this product were approximately $705 million, according to data released by Symphony Health.

AbbVie came into existence earlier this year following its separation from Abbott Laboratories (ABT). AbbVie recently provided its guidance for 2013. The company expects to earn $3.03-$3.13 per share in 2013 on total revenues of more than $18 billion. Currency movement is expected to negatively impact revenues by about 1%.

We remind investors that recently Perrigo - developer, manufacturer and distributor of over-the-counter (OTC) and generic prescription pharmaceuticals among others - reported lower-than-expected revenues, but higher-than-expected earnings in its second quarter 2013 (ended Dec 29, 2012).

Perrigo currently carries a Zacks Rank #3 (Hold) in the short-run. We have a similar stance on AbbVie, a large-cap pharma stock. However, another large-cap pharma stock Sanofi (SNY) currently appears to be more favorably placed . The company carries a Zacks Rank #1 (Strong Buy).


FDA Clears Testosterone Gel - Analyst Blog

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