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FDA Approves Combivent Respimat with New Inhaler

[ Price : $8.95]

FDA approves a Boehringer Ingelheim Pharmaceuticals NDA for Combivent Respimat (ipratropium bromide and albuterol), a new propella...

Court Grants Restraining Order on Generic Lovenox

[ Price : $8.95]

Massachusetts federal court grants a temporary restraining order to prevent Watson Pharmaceuticals and Amphastar from marketing Am...

FDA 'Fast Track' for DARA Pain Drug

[ Price : $8.95]

FDA grants a fast track designation for DARA BioSciences' KRN5500 for treating neuropathic pain in patients with cancer.

FDA Approves Onco's Generic Cladribine

[ Price : $8.95]

FDA approves an Onco Therapies ANDA for a generic copy of Janssen's Luestatin.

Banner Pharmacaps ANDA for Generic Targretin

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FDA accepts for review a Banner Pharmacaps ANDA for a generic version of Eisai's Targretin.

FDA Continues Hold on Cystic Fibrosis Trial

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FDA maintains a clinical hold on an Insmed Phase 3clinical trial for Arikace (liposomal amikacin for inhalation) in cystic fibrosi...

FDA Clears a Cardium Therapeutics 510(k) for Wound Product

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FDA clears a Cardium Therapeutics 510(k) for the Excellagen professional-use, sterile, syringe-based advanced wound care product f...

FDA Approves Januvia/Zocor Combo Pill

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FDA approves an MSD International GmbH Clonmel NDA for Juvisync (sitagliptin and simvastatin), a fixed-dose convenience combinatio...

FDA, CMS Pilot Parallel Reviews for Devices

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FDA and the Centers for Medicare & Medicaid Services (CMS) launch a parallel review two-year pilot program for approving medical d...

Correction Made in OMB Approval of Tobacco Exemption Info

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Federal Register Notice: FDA corrects an expiration date in a 9/12 Federal Register notice on OMB approval of an information colle...