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Archive for April, 2007

FDA confirms Mylan’s version is only approved amlodipine

Monday, April 30th, 2007

The FDA has confirmed Mylan’s current status of having the only approved ANDA for all strengths of amlodipine besylate, which is a generic version of Pfizer’s Norvasc (Source: Drug Topics – Hot off the Press)

New Indication For SINGULAIR® (Montelukast Sodium) Approved To Prevent Exercise-Induced Bronchoconstriction

Friday, April 27th, 2007

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for SINGULAIR® (montelukast sodium) to prevent exercise-induced bronchoconstriction (EIB; also known as exercise-induced asthma) in patients aged 15 years and older. SINGULAIR is the first and only oral tablet approved for this use. EIB is typically characterized by shortness of breath, cough, wheeze and chest tightness brought on by exercise. [click link for full article] (Source: Asthma / Respiratory News From Medical News Today)

UCB reports results from phase III trial investigating levetriracetam (Keppra) for partial onset seizures in children aged under 4 years

Friday, April 27th, 2007

National electronic Library for Medicines (NeLM) (Source: CEBMH News | News Front Page)

Receiving Restylane or Botox?

Friday, April 27th, 2007

Have you had Restylane or Botox injections in the last month, or do you have a confirmed appointment in the next two months? (Source: dukehealth.org: Duke Clinical Trials)

New Indication for SINGULAIR® (montelukast sodium) Approved to Prevent Exercise-Induced Bronchoconstriction

Friday, April 27th, 2007

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for SINGULAIR® (montelukast sodium) to prevent exercise-induced bronchoconstriction (EIB; also known as exercise-induced asthma) in patients aged 15 years and older. SINGULAIR is the first and only oral tablet approved for this use. (PRWeb Apr 26, 2007) Post Comment:Trackback URL: http://www.prweb.com/pingpr.php/SG9yci1DcmFzLUluc2UtUHJvZi1NYWduLVplcm8= (Source: PRWeb: Medical Pharmaceuticals)

Singulair Approved for Exercise-Induced Asthma

Thursday, April 26th, 2007

Title: Singulair Approved for Exercise-Induced AsthmaCategory: Health NewsCreated: 4/26/2007 2:00:00 AMLast Editorial Review: 4/26/2007 (Source: MedicineNet Asthma General)

Merck Singulair OK’d for exercise asthma

Wednesday, April 25th, 2007

Merck said Wednesday the U.S. Food and Drug Administration approved Singulair for preventing exercise-induced asthma. (Source: United Press International – Health Business)

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New Indication for SINGULAIR® (montelukast sodium) Approved to Prevent Exercise-induced Bronchoconstriction

Tuesday, April 24th, 2007

(Source: Merck.com – Product News)

UCB reports results from phase III trial investigating levetiracetam (Keppra) for partial onset seizures in children aged under 4 years

Sunday, April 22nd, 2007

UCB has announced results from a phase III, double-blind, randomised, placebo-controlled study evaluating the efficacy and tolerability of levetiracetam (Keppra®) (20-50 mg/kg/day) as adjunctive therapy in the treatment of partial onset seizures in children (n=116) from one month to less than four years of age. They state that compared with placebo, levetiracetam was shown to significantly reduce the frequency of partial onset seizures in these paediatric patients with consistent results across all stratified age groups. They report that in this study, 43.1% of levetiracetam-treated patients experienced at least a 50% reduction in seizure frequency during the evaluation period of 5 days, compared with 19.6% of placebo-treated patients. The most common adverse events that occurred in…

Citing ‘De Facto’ MDL, Mirapex Defendants Seek Transfer To Official Court

Sunday, April 22nd, 2007

WASHINGTON, D.C. – Saying a plaintiff law firm has created a de facto multidistrict litigation court for Mirapex injury lawsuits, Boehringer Ingelheim Pharmaceuticals Inc. and Pfizer Inc. on Jan. 30 asked the Judicial Panel on Multidistrict Litigation to officially create an MDL for the drug cases (In Re: Mirapex Product Liability Litigation, MDL Docket No. 1836, JPMDL). Full story on lexis.com (Source: LexisNexis® Mealey’s™ Emerging Drugs & Devices Legal News)

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