Biotech Values

[DewDiligence]

Mylan refiles ‘authorized generics’ suit vs. FDA

[Does anyone care to handicap the outcome? Does anyone think MYL has any chance at all of prevailing?]

http://tinyurl.com/6s5zd

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WASHINGTON, Nov 16 (Reuters) - Mylan Laboratories Inc. (MYL) refiled its suit against the U.S. Food and Drug Administration over brand name drugmakers' deals with generic companies to allow "authorized generics," the FDA's top lawyer said on Tuesday.

FDA Chief Counsel Daniel Troy said the new suit "adds a wide variety of antitrust claims" related to a deal between Procter & Gamble Co. (PG) and Watson Pharmaceuticals Inc. (WPI).

In March, Mylan launched a generic version of Procter & Gamble's Macrobid, an antibiotic used to treat urinary tract infections. But Proctor & Gamble licensed a separate, "authorized" version to Watson.

Mylan says authorized generics interfere with a 180-day period of market exclusivity that a company is supposed to receive if it is the first to win approval for a generic copy of a brand-name medicine. The company wants the FDA to stop the practice.

Mylan officials could not immediately be reached for comment late Tuesday.

Troy said the FDA was "highly confident" in its position that authorized generics were permissible.

"Two judges who have at least addressed the issue orally have agreed with us," he said.

He said Mylan should work to resolve any antitrust issues with Procter & Gamble and Watson directly.
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