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Teijin owns the trademark for the drug and licenses it to Takeda, and both companies responded to the filing with a patent-infringement suit against Mylan.
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PI's rights to discuss or publish trial results after the trial is completed.
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Accordingly, Woodcock announced that the Office of Pharmaceutical Science(OPS), Office of Generic Drugs (OGD) and Office of Manufacturing and ProductQuality (OMPQ) and Office of Compliance (OC) would both be ceding some of theirquality functions to OPQ.
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In their lawsuit, while all the generic companies excluding Apotex conceded that their versions infringed upon Crestor's patent, they claimed that the patent covered an obvious variation of earlier compounds.
Last year's dip was due to a number of widely-used brand-name drugs losing patent protection, the report notes, and forecasts that low rates of growth in prescription drug spending, and hospital expenditures, will continue this year.
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Bimatoprost is used to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (e.
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Early diagnosis and prompt treatment in order to prevent the serious consequences of increased intraocular pressure are a major concern of health care professionals.
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Continue using it for the full time prescribed.
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Lumigan is a prescription medicine used for reducing eye pressure in people with open angle glaucoma or ocular hypertension.
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Actavis said it was likely the first company to file a complete ANDA for a generic version of Lamictal ODT and, as such, would be eligible for 180 days of market exclusivity in which to compete directly with the branded version.
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How often does that side effect happen and who is at risk?
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Par stated it was the first company to file a complete regulatory approval application for a generic version of the drug, thus entitling it to 180 days of market exclusivity in which to compete directly with the brand.
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These drugs work by decreasing fluid () production in the eye and now are often prescribed as an adjunct to or in combination with prostaglandins.
Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic solutions.
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.
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