FDA Clears Testosterone Gel

Recommended by Dr. Michael White, Updated on January 27th, 2018
Reading Time: 2 minutes

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).

Apart from announcing its financial results, Perrigo inked a deal to buy animal health company Velcera, Inc. for $160 million in cash. The deal is expected to close in calendar year 2013. Perrigo intends to strengthen its position in the OTC retail pet healthcare market through the impending acquisition.

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).

Read the Full Research Report on ABBV

Read the Full Research Report on SNY

Read the Full Research Report on ABT

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FDA Clears Testosterone Gel

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