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FDA Approvals - Sirion Therapeutics Announces FDA Approval Of Durezol(TM) For Treatment Of


Sirion Therapeutics Announces FDA Approval Of Durezol(TM) For Treatment Of Postoperative Ocular Inflammation And Pain (Medical News Today)
Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a six month priority review.

Taro Receives Final FDA Approval For RX Cetirizine Hydrochloride Syrup ANDA (Medical News Today)
Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF, "Taro", the "Company") reported that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for prescription Cetirizine Hydrochloride Syrup, 1 mg / 1 mL ("cetirizine syrup"). Taro had received tentative approval for this ANDA in October 2007.

New England Research Institutes, Inc., Assists Medtronic, Inc., In Obtaining FDA Approval Of The TalentTM Abdominal ... (Medical News Today)
New England Research Institutes, Inc. (NERI), a global, privately held specialty Contract Research Organization (CRO), announced that their statistical analysis of data in The Lifeline Registry of Endovascular Aneurysm Repair (EVAR) contributed to the recent FDA approval of Medtronic, Inc.'s TalentTM Abdominal Stent Graft.
 

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