NEW YORK ( TheStreet) -- Shares of Endo Pharmaceuticals ( ENDP) rose in extended action late Wednesday after the Chadds Ford, Pa.-based drug developer received regulatory approval for its Fortesta gel product for the treatment of men with low testosterone.

The Food and Drug Administration approved Fortesta as a Class III product for topical use, and Endo expects to launch the product in the United States in early 2011.

The stock was last quoted at $36.71, up 4.2%, according to, although trading was light at around 10,000 shares. The issue's trailing three-month daily average volume is around 1.5 million. Based on a regular session close at $35.22, the shares have appreciated by more than 70% in 2010.

Endo estimates nearly 14 million men in the United States have low testosterone and that roughly 1.3 million, or 9%, are being treated for the condition.

Of the 25 analysts covering Endo's stock, eight rate it at strong buy, five at buy and 12 are at hold. Wall Street's median 12-month price target is $40, implying upside of more than 13% from current levels.

The current average estimate of analysts polled by Thomson Reuters is for Endo to earn 94 cents a share on revenue of $461.1 million in the current quarter ending this month. That performance would be above its profit of 86 cents a share on revenue of $444.1 million in the September-ended quarter.

Duncan Williams Inc., a Memphis, Tenn.-based investment banking firm, reiterated a strong buy rating on Endo's stock on Wednesday ahead of the news. The firm said it's modeling for 2011 sales of $14 million for Fortesta, and that it sees a "difficult reimbursement environment" for the product, as well as competitive pressures from "the overlapping launch" of Eli Lilly's ( LLY) Axiron.

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