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The Pittsburgh Business Times - July 10, 2003
http://pittsburgh.bizjournals.com/pittsburgh/stories/2003/07/07/daily37.html

9:27 AM EDT Thursday

FDA closer to approving Mylan drug for Parkinson's

Mylan Laboratories Inc. said the Food and Drug Administration tentatively approved a new drug for Parkinson's disease.

Mylan said its brand-name subsidiary, Bertek Pharmaceuticals Inc., received an "approvable" letter from the FDA for the
drug, apomorphine hydrochloride. The FDA has requested additional information before it decides whether to give the
drug final approval.

The FDA accepted Bertek's new drug application for apomorphine in January and granted it fast-track status. The drug is
injected under the skin to treat so-called off periods of Parkinson's disease, when patients experience sudden and
debilitating periods of total or partial immobility.

Bertek, of Research Triangle Park, N.C., develops and licenses proprietary pharmaceuticals with an emphasis on
dermatology, neurology and cardiology. Mylan is based in Canonsburg.

SOURCE: The Pittsburgh Business Times / American City Business Journals Inc
http://pittsburgh.bizjournals.com/pittsburgh/stories/2003/07/07/daily37.html?t=printable

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