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FDA OKs Tevas Generic Pulmicort While Dismissing Petition

[ Price : $8.95]

In the face of an ongoing federal court patent suit, FDA approves a Teva Pharmaceutical Industries ANDA for a generic version of A...

Experts Question FDA China Office Success

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FDA opens its three offices in China amid expert concern that they will not be able to do the work expected of them.

FDA Changes Some Requirements for Generic Miacalcin

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FDA grants some restrictions on ANDA and 505(b)(2) applications for salmon calcitonin nasal spray products sought by Miacalcin Nas...

Barton Seeks GAO Study on FDAs Heparin Actions

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Texas Republican Joe Barton calls for a thorough GAO study on FDAs handling of the tainted heparin issue, calling into question th...

Lumpkin Given FDLI Distinguished Service Award

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FDLI awards FDA deputy commissioner for international and special programs Murray Lumpkin its 2009 Distinguished Service and Leade...

CGMP, Other Problems at Deltex Pharmaceuticals

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FDAs Dallas District Office warns Deltex Pharmaceuticals about cGMP problems at its drug manufacturing facility, along with market...

Quality, Reporting Problems Found at Ophthalmic Technologies

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CDRH warns Canadas Ophthalmic Technologies for QS and MDR violations and says an Import Alert has been issued for its devices.

Glaxo Resolves Injectable Argatroban Supply Shortage

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FDA reports that GlaxoSmithKline has resumed normal supply shipments of argatroban for injection that had been in short supply due...

Subpoena Threatened in PR-gate Probe

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Reps. John Dingell and Bart Stupak say FDA has not delivered all records and materials requested for a committee probe into a cont...

FDA Extends Review of Wilmingtons Metazolv NDA

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FDA extends by three months its review of a Wilmington Pharmaceuticals NDA for Metozolv orally disintegrating tablets.