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Lillys Evista Gets New Black Box Warning

[ Price : $8.95]

FDAs September drug safety labeling changes includes a new boxed warning on an increased risk of venous thromboembolism and death ...

Breast Implants Must be Tracked

[ Price : $8.95]

CDRH says silicone gel-filled breast implants are subject to device tracking requirements.

FDA Looking at Bupropion Complaints

[ Price : $8.95]

FDA looks at consumer complaints about generic Wellbutrin XL and lab tests indicating it releases the active ingredient too fast.

Guidance on Impact-Resistant Lenses

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Federal Register Notice: FDA releases a draft guidance on impact-resistant lenses.

FDA to Ensure Exocrine Pancreatic Insufficiency Drugs

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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

[ Price : $8.95]

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...