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News Breaks
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January 30, 2012
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| 08:16 EDT |  | LCI, WPI |
| theflyonthewall.com: | Lannett receives FDA approval for Hydrochlorothiazide Capsules, 12.5mg | | Lannett Company (LCI) announced it has received approval from the FDA of its Abbreviated New Drug Application for Hydrochlorothiazide Capsules, 12.5 mg. Hydrochlorothiazide Capsules, 12.5 mg, is therapeutically equivalent to the reference listed drug, Microzide Capsules, 12.5 mg, of Watson Pharmaceuticals (WPI). Sales of Hydrochlorothiazide Capsules, 12.5 mg, at Average Wholesale Price were approximately $204M for the 12 months ending October 2011, according to Wolters Kluwer. Shipping is expected to commence shortly. :theflyonthewall.com |
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May 24, 2012
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| 16:09 EDT | | WPI |
| theflyonthewall.com: | Watson confirms Testim patent challenge, Paragraph IV litigation underway | | Watson Pharmaceuticals (WPI) confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Testosterone Gel, 1%. Watson's 1% testosterone gel product is a generic version of Auxilium Pharmaceuticals' (AUXL) Testim® 1%. Testim®1% is indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Auxilium and FCB I LLC filed suit against Watson on May 23 in the United States District Court for the District of New Jersey seeking to prevent Watson from commercializing its 1% testosterone gel product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. :theflyonthewall.com |
| | 10:29 EDT |  | WPI |
| | 05:59 EDT | | WPI |
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May 17, 2012
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| 08:57 EDT |  | WPI |
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