"Multaq Not a Very Safe Drug" - Lawyers and Settlements

In fact, Multaq side effects are compelling. But even though the US Food and Drug Administration (FDA) has Multaq under a microscope and issued a cautionary statement about dronedarone (Multaq) as recently as February, the agency is resisting any effort to ...

Indian Drug Regulator Accused of Corruption and Collusion - Businessweek

At least two medicines, Paris-based Sanofi (SAN)’s dronedarone and aliskiran from Basel, Switzerland-based Novartis were approved on the basis of trials that were conducted on less than 50 people in India, even though the laws require a ...

Medical body demands ban on 33 drugs in India - deccanchronicle.com

Pyridoxine & Folic Acid (Theon); * Clinical trials were conducted for Dronedarone (Sanofi) and Aliskiran (Novartis) on just 21 and 46 patients respectively as against the statutory requirement of at least 100 patients. * In case of Irsogladine (Macleods ...

MMRL Scientists Present Ten Lectures and Papers at International Heart Rhythm Society Meeting - TMCnet

Two other lectures dealt with the recent exciting discovery by MMRL investigators that the combination of ranolazine and dronedarone, causes a synergistic depression of sodium channel current in the upper but not lower chambers of the heart ...

Study Reports Catheter Ablation Superior to Drug Therapy as First-Line Treatment for Atrial Fibrillation - Yahoo Finance

Patients in the drug therapy arm were prescribed Dronedarone,* Flecainide,* Propafenone,* Sotalol* or Amiodarone. The study patients were followed for two years. Catheter ablation was performed on day zero or the anti-arrhythmic drug therapy was ...

Post-marketing surveillance of approved drugs not complied with by pharma cos: Parliament panel - pharmabiz.com

The panel also found that the PSURs were not being submitted in time as per the rules. In the case of two drugs of MNCs (dronedarone of Sanofi Aventis and pemetrexid of Eli Lilly), the PSURs were neither India specific nor in the approved format as ...

India’s drug regulation system is in a total shambles - Daily Mail

In the case of 11 drugs, phase three clinical trials mandated under the law were not conducted. In the case of two drugs, Dronedarone by Sanofi and Aliskiran by Novartis, clinical trials were conducted in just 21 and 46 patients respectively as against the ...

Drugs Being Approved Without Human Trials In India, Says Report - thelinkpaper.ca

Some of these drugs belong to reputed firms like Novartis, Cipla and Eli Lily. In the case of two drugs (Dronedarone of Sanofi and Aliskiran of Novartis), trials were conducted only on 21 and 46 patients, respectively, as against the stipulated 100.

India’s drug regulation in shambles - in.news.yahoo.com

In the case of 11 drugs, phase three clinical trials mandated under the law were not conducted. In the case of two drugs, Dronedarone by Sanofi and Aliskiran by Novartis, clinical trials were conducted in just 21 and 46 patients respectively as against the ...

Johnson & Johnson : Study Reports Catheter Ablation Superior to Drug Therapy as First-Line Treatment for Atrial Fibrillation - 4-traders (press release)

Patients in the drug therapy arm were prescribed Dronedarone,* Flecainide,* Propafenone,* Sotalol* or Amiodarone. The study patients were followed for two years. Catheter ablation was performed on day zero or the anti-arrhythmic drug therapy was optimized ...