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FDA Clears Body Fat Laser

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FDA clears an Erchonia Corp. 510(k) for the company's contouring laser called Zerona, intended for use for circumferential reducti...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites B&A Health Products and Frontier Medical Products.

Actress Florence Henderson Promoting Crystalens IOL

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Actress Florence Henderson says she is appearing in an integrated Bausch & Lomb promotional campaign for its Crystalens intraocula...

Lipton Green Tea is Unapproved New Drug

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FDAs Center for Food Safety and Applied Nutrition says Lipton is promoting its Green Tea product to treat or mitigate health condi...

FDA Does an 'About Face' on ProAmatine Withdrawal

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Pressure from patients and healthcare providers persuades FDA to reverse its decision to seek the immediate withdrawal of Shire's...

Watson Labs ANDA for Generic Combigan

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Watson Labs files an ANDA seeking approval to market brimonidine tartrate and timolol maleate ophthalmic solution (0.2%/0.5%), a g...

FDA Clears Teleflex Catheter with Antimicrobial Coating

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FDA clears a Teleflex 510(k) for the ArrowEvolution PICC with Chlorag+ard technology, a peripherally inserted central catheter wit...

Advisors Recommend Ceftaroline Approval

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The FDA Anti-infective Drugs Advisory Committee recommends approval of Forests ceftaroline for two indications.

Celgene Notified of Paragraph 4 ANDA for Revlimid

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Celgene says it has received a Paragraph 4 certification letter from Natco Pharma Ltd. (Hyderabad, India) on its recent ANDA submi...

Ranbaxy Hopeful on Resolving Export Ban

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Daiichi Sankyo says it is making progress with FDA in lifting a ban on exports from two of its Ranbaxy subsidiary''s generic drug ...