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First Generic Ropinirole, Approved by The FDA Title: First Generic Ropinirole, Approved by The FDA
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Filed in archive FDA Approvals , Neurological Disorders , Treatment by Gloria Gamat on May 09, 2008

Requip (ropinirole hydrochloride) tablets - product of GlaxoSmithKline (GSK) - are for the treatment of moderate to severe Restless Legs Syndrome (RLS). © Brymo From the NINDS-NIH: Restless legs...

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UCB's Cimzia: FDA-Approved for Chron's Disease Title: UCB's Cimzia: FDA-Approved for Chron's Disease
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Filed in archive FDA Approvals , Treatment by Gloria Gamat on April 24, 2008

With no cure and still of unknown cause - Crohn's disease - is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. Chron's disease can cause...

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Rotavirus-Caused Gastroenteritis Vaccine Rotarix: Approved by US FDA Title: Rotavirus-Caused Gastroenteritis Vaccine Rotarix: Approved by US FDA
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Filed in archive Diarrhea , Digestive Disorders , FDA Approvals , Treatment , Viruses and Viral Infection by Gloria Gamat on April 04, 2008

Rotarix - the second oral U.S. licensed vaccine for the prevention of rotavirus (an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children) - has been approved by the...

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Fibrin Sealant, Artiss: FDA-Approved for Burn Patients Title: Fibrin Sealant, Artiss: FDA-Approved for Burn Patients
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Filed in archive FDA Approvals , News by Gloria Gamat on March 19, 2008

A new medical adhesive - a fibrin sealant - called Artiss for use in attaching skin grafts onto burn patients, has just been approved by the US FDA. Fibrin sealants are tissue adhesives that contain...

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Nexium, FDA-Approved for Pediatric GERD Title: Nexium, FDA-Approved for Pediatric GERD
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Filed in archive FDA Approvals , Treatment by Gloria Gamat on March 04, 2008

Last week, the FDA has approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium...

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Arcalyst: New Orphan Drug FDA-Approved for Treatment of Rare Inflammatory Syndromes Title: Arcalyst: New Orphan Drug FDA-Approved for Treatment of Rare Inflammatory Syndromes
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Filed in archive FDA Approvals , News , Treatment by Gloria Gamat on February 28, 2008

The FDA has just approved a new orphan drug for the treatment of rare inflammatory syndromes. The said dug - Arcalyst - is the first treatment for an extremely rare condition known as...

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Abbott's HUMIRA(R) (adalimumab) FDA-Approved For Moderate to Severe Chronic Plaque Psoriasis Title: Abbott's HUMIRA(R) (adalimumab) FDA-Approved For Moderate to Severe Chronic Plaque Psoriasis
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Filed in archive FDA Approvals , Psoriasis & Skin Diseases , Treatment by Gloria Gamat on January 21, 2008

The US FDA has recently approved the marketing of Abbott's HUMIRA(R) (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis. Plaque psoriasis is an...

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Tysabri (natalizumab): Approved by FDA For Moderate-to-Severe Crohn's Disease Title: Tysabri (natalizumab): Approved by FDA For Moderate-to-Severe Crohn's Disease
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Filed in archive Digestive Disorders , FDA Approvals , Treatment by Gloria Gamat on January 15, 2008

Previously approved for use in the treatment of some forms of multiple sclerosis (MS) - Tysabri (natalizumab) - is now approved by the FDA for the treatment of moderate-to-severe Crohn's disease...

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xTAG Respiratory Viral Panel, FDA-Cleared for Marketing Title: xTAG Respiratory Viral Panel, FDA-Cleared for Marketing
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Filed in archive Diagnostics , FDA Approvals , Viruses and Viral Infection by Gloria Gamat on January 07, 2008

The FDA has recently cleared for marketing, the very first test that can simultaneously detect and identify 12 specific respiratory viruses in one sample. The said test, called the xTAG Respiratory...

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Voluven®: Approved by the FDA for Treatment of Serious Blood Volume Loss, Post-Surgery Title: Voluven®: Approved by the FDA for Treatment of Serious Blood Volume Loss, Post-Surgery
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Filed in archive FDA Approvals , Treatment by Gloria Gamat on December 29, 2007

The FDA has recently approved Voluven® for the treatment of serious blood volume loss following surgery. Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma...

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Bystolic™ (nebivolol): New Beta Blocker, FDA-Approved Title: Bystolic™ (nebivolol): New Beta Blocker, FDA-Approved
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Filed in archive Cardiovascular Health , FDA Approvals , Treatment by Gloria Gamat on December 22, 2007

Sponsored by Mylan Bertek Pharmaceuticals Inc. and sold and marketed by New York City-based Forest Laboratories, Inc. - Bystolic™ (nebivolol) - has recently been approved by the FDA for the...

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Kuvan® (sapropterin dihydrochloride): FDA-Approved for Phenylketonuria (PKU) Title: Kuvan® (sapropterin dihydrochloride): FDA-Approved for Phenylketonuria (PKU)
PermaLink: http://www.straightfromthedoc.com/50226711/kuvana_sapropterin_dihydrochloride_fdaapproved_for_phenylketonuria_pku.php

Filed in archive FDA Approvals , Genetics , Treatment by Gloria Gamat on December 19, 2007

Phenylketonuria (PKU) is a rare genetic disorder that causes mental retardation, smaller brain size, delayed speech and other neurological problems. If diabetes is characterized by the body not being...

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FDA's Safety Reviews: No Evidence That Use of Prilosec and Nexium Increase Rates of Cardiac Events Title: FDA's Safety Reviews: No Evidence That Use of Prilosec and Nexium Increase Rates of Cardiac Events
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Filed in archive Cardiovascular Health , Digestive Disorders , FDA Approvals , News by Gloria Gamat on December 12, 2007

Both products of AstraZeneca - Prilosec and Nexium - are members of a class of drugs known as proton pump inhibitors (PPIs) and are indicated for the treatment of severe gastroesophageal reflux...

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Nexavar® (sorafenib), FDA-Approved for Inoperable Hepatocellular Carcinoma Title: Nexavar® (sorafenib), FDA-Approved for Inoperable Hepatocellular Carcinoma
PermaLink: http://www.straightfromthedoc.com/50226711/nexavara_sorafenib_fdaapproved_for_inoperable_hepatocellular_carcinoma.php

Filed in archive Cancer , FDA Approvals , Treatment by Gloria Gamat on November 21, 2007

Originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma (a form of kidney cancer) - Nexavar® (sorafenib) has recently been approved by the FDA for use in...

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Nonprescription Zyrtec-D for Allergies, FDA-Approved Title: Nonprescription Zyrtec-D for Allergies, FDA-Approved
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Filed in archive Allergies , FDA Approvals , Treatment by Gloria Gamat on November 10, 2007

A combination of antihistamine with a nasal decongestant, Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg) is a prescription allergy drug from Pfizer. Now, the FDA has approved a Zyrtec-D...

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Tasigna (nilotinib), FDA-Approved for Philadelphia Chromosome Positive CML Title: Tasigna (nilotinib), FDA-Approved for Philadelphia Chromosome Positive CML
PermaLink: http://www.straightfromthedoc.com/50226711/tasigna_nilotinib_fdaapproved_for_philadelphia_chromosome_positive_cml.php

Filed in archive Cancer , FDA Approvals , Treatment by Gloria Gamat on October 30, 2007

Novartis Pharma's Tasigna (nilotinib) has recently been approved by the US FDA for the treatment of Philadelphia chromosome positive chronic myeloid leukemia (CML) in adult patients whose disease...

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New FDA-Approved Label of ED Drugs Contains Risk of Hearing Loss Title: New FDA-Approved Label of ED Drugs Contains Risk of Hearing Loss
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Filed in archive FDA Approvals , Men's Health , News by Gloria Gamat on October 24, 2007

Revisions of the labeling of ED drugs (Cialis, Levitra and Viagra) that includes the potential risk of sudden hearing loss have already been approved by the FDA. The said approval will also apply for...

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New Bristol-Meyers Squibb's New Anti-Cancer Treatment: Ixempra, FDA-Approved Title: New Bristol-Meyers Squibb's New Anti-Cancer Treatment: Ixempra, FDA-Approved
PermaLink: http://www.straightfromthedoc.com/50226711/new_bristolmeyers_squibbs_new_anticancer_treatment_ixempra_fdaapproved.php

Filed in archive Cancer , FDA Approvals , Treatment by Gloria Gamat on October 22, 2007

A new anti-cancer treatment distributed by Bristol-Meyers Squibb Company (Princeton, New Jersey) -Ixempra (ixabepilone) - has recently been approved by the US FDA for use use in patients with...

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Doribax (doripenem injection), FDA-Approved for Complicated Urinary Tract and Intra-abdominal Infections Title: Doribax (doripenem injection), FDA-Approved for Complicated Urinary Tract and Intra-abdominal Infections
PermaLink: http://www.straightfromthedoc.com/50226711/doribax_doripenem_injection_fdaapproved_for_complicated_urinary_tract_and_intraabdominal_infections.php

Filed in archive Bacteria and Bacterial Infections , FDA Approvals , Treatment by Gloria Gamat on October 18, 2007

Currently, the prescribed medication for the treatment of complicated urinary tract infections is levofloxacin while meropenem for complicated intra-abdominal infections. Found to have a cure rate...

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