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FDA to Ensure Exocrine Pancreatic Insufficiency Drugs

[ Price : $8.95]

Federal Register Notice: FDA intends to exercise enforcement discretion to ensure availability of exocrine pancreatic insufficienc...

FDA Clears Mosaic Spinal System

[ Price : $8.95]

FDA clears a Spinal Elements 510(k) for the Mosaic Spinal System intended for use as a cervical intervertebral body fusion device.

Barr Seeks OK for Generic of Alcon''s Patanol

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Barr Pharmaceuticals says it has filed an ANDA for a generic copy of Alcons eye allergy drug Patanol.

Prasugrel Tests Suspended

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Lilly and Daiichi Sankyo suspend a Phase 2 pharmacodynamic prasugrel trial.

Genta Appeals Genasense Non-approvable Decision

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Genta files a formal appeal of CDERs 12/06 non-approvable letter on Genasense, indicated for use with chemotherapy in patients wit...

OMB OKs Info on Continuous Marketing Applications

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Federal Register Notice: The Office of Management and Budget approves information on a guidance on continuous marketing applicatio...

FDA Creates Pediatric Review Committee

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FDA creates a Pediatric Review Committee to look at pediatric information submitted in pediatric plans, assessments, and studies.

FDA Clears Vertebrae Fusion Support System

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FDA clears an Alphatec Holdings 510(k) for the Dynamo Rod System, intended for use in vertebrae fusion surgeries.

FDA OKs Luitpold Pharma sNADA on Phenylbutazone

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Federal Register Final rule: FDA approves a Luitpold Pharmaceuticals NADA for a revised human food safety warning on phenylbutazon...

FDA OKs Elanco Animal Health Drug for Dog Fleas

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Federal Register Final rule: FDA approves an Elanco Animal Health NADA for veterinary prescription use of spinosad chewable tablet...