August 14, 2008
Audience: Cardiologists, hospital risk managers [Posted 08/14/2008] Boston Scientific and FDA informed healthcare professionals...
August 12, 2008
Audience: Primary healthcare physicians, internists, other healthcare professionals[Posted 08/12/2008] FDA informed healthcare...
August 12, 2008
Audience: Pain management specialists, risk managers, other healthcare professionals, patients[UPDATED 08/12/2008] Watson...
August 8, 2008
Audience: Oncologists, other healthcare professionals[Posted 07/31/2008] FDA informed healthcare professionals of modifications...
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Cleviprex
Cleviprex is an intravenous, ultrashort-acting calcium channel blocker under development for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable.
Stavzor
Stavzor is delayed-release valproic acid formulated in the EnteriCare enteric soft gelatin capsule delivery system designed to minimize GI adverse events. Stavzor is indicated for the treatment of manic episodes associated with bipolar disorder,
adjunctive therapy in multiple seizure types (including epilepsy),
and prophylaxis of migraine headaches.
Navstel
Navstel is a balanced salt ophthalmic solution for use as an intraocular irrigation during surgical procedures involving perfusion of the eye.
Eovist
Eovist (gadoxetate disodium) is a gadolinium-based contrast agent for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize
lesions in adults with known or suspected focal liver disease.
Evolence
Evolence is a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.
Kinrix
Kinrix [Diphtheria and
Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated
Poliovirus Vaccine] is a combination vaccine
for protection against diphtheria, tetanus, pertussis and polio diseases in children.
Durezol
Durezol (difluprednate ophthalmic emulsion) is a topical steroid for the treatment of postoperative ocular inflammation and pain.
PrandiMet
PrandiMet (repaglinide and metformin HCl) is a fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin) and insulin sensitizer,
metformin, indicated for the treatment of type 2 diabetes.
Pentacel
Pentacel is a combination vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age.
Trivaris
Trivaris (triamcinolone acetonide) is a glucocorticoid corticosteroid delivered via intravitreal injection for the treatment of sympathetic ophthalmia, temporal
arteritis, uveitis, and ocular inflammatory conditions unresponsive
to topical corticosteroids.
Entereg
Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.
OraVerse
OraVerse is a dental anesthetic reversal agent that accelerates the return to normal sensation and function following dental procedures.
Aplenzin
Aplenzin is a once-daily formulation of bupropion hydrobromide indicated for the treatment of depression in adults.
Cimzia
Cimzia is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of moderately to severely active Crohn’s disease in adults.
Relistor
subcutaneous injection for the treatment of opioid-induced constipation
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