UPDATE 3-Watson's Florida plant clears FDA inspection
(Adds company comments)
NEW YORK, April 29 (Reuters) - Watson Pharmaceuticals Inc (WPI.N: Quote, Profile, Research) said on Tuesday the U.S. Food and Drug Administration completed an inspection at a Florida manufacturing plant, potentially clearing the way for approvals of generic drugs made at the site, sending the company's shares up more than 7 percent.
The FDA told Watson it has removed the Official Action Indicated status at the Davie, Florida, plant, which has been under OAI status since 2005.
During that time, Watson said it has continued to file applications for generic drugs to be manufactured at this site, but the FDA has withheld approval pending positive resolution of the OAI status.
Watson, which acquired the Davie plant and its regulatory problems when it bought Andrx Corp in 2006, said it is working with the FDA on securing approvals for generic drugs to be made at the plant.
Although the plant has been operating during this period, it has been under-utilized, Watson spokeswoman Patty Eisenhaur said.
Eisenhaur said the company's most immediate new product opportunities from the plant include generic versions of a 40 milhigram dosage of the acid reflux medicine Prilosec and heart drug Toprol XL.
Other products include generic versions of blood-pressure treatment Cardizem LA and of the attention deficit hyperactivity disorder drugs Adderall XR and Concerta.
Goldman Sachs analyst Randall Stanicky said the removal of the OAI was positive for Watson, although he does not expect any significant change to the company's outlook because it had factored a "mid-year" removal into its previous forecast.
Watson shares were up $2.10, or 7.2 percent, to $31.24 in afternoon trading on the New York Stock Exchange. (Reporting by Lewis Krauskopf, editing by Mark Porter and Maureen Bavdek)
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