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FDA Alerts

U.S. Lawmakers Probe FDA Approval of Ranbaxy Drugs

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
Two leading U.S. Democrats said on Tuesday they are investigating whether Food and Drug Administration knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data.

The congressional investigation stems from information released as part of a probe by U.S. law enforcement authorities into whether the Indian drugmaker submitted false data to support generic drug applications and tried to hide manufacturing violations, the lawmakers said.

Read more: U.S. Lawmakers Probe FDA Approval of Ranbaxy Drugs

Drug Misuse Partially Accounts for Excess Mortality in Scotland

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
Mortality rates in Scotland are substantially higher than in England and Wales - the so-called "Scottish effect." New research suggests that loss of life related to problem drug use accounts for a significant portion of the excess death rate.

Read more: Drug Misuse Partially Accounts for Excess Mortality in Scotland

FDA Approvals: KINRIX and Metvixia

  • Written by News Author: Yael Waknine CME Author: Yael Waknine
  • Category: FDA Alerts
The US Food and Drug Administration (FDA) has approved a combination vaccine that offers protection against diphtheria, tetanus, pertussis, and polio in a single shot; and the use of methyl aminolevulinate 16.8% cream with a narrow-band, red-light device equipped with light-emitting diodes for the treatment of actinic keratoses.

Read more: FDA Approvals: KINRIX and Metvixia

HHS Announces New International Programs to Enhance Drug and Food Safety

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
Joint Inspections with European Union and Australian Regulators; Third-Party Certification Program Are Latest Steps toward Implementing New Import Strategy
U.S. Health and Human Services (HHS) Secretary Mike Leavitt today announced two groundbreaking programs designed to enhance the safety of food and medical products exported to the United States.

Read more: HHS Announces New International Programs to Enhance Drug and Food Safety

Cymbalta® is now approved for fibromyalgia

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) indicated in adults for

  • Acute and maintenance treatment of major depressive disorder (MDD)
  • Management of diabetic peripheral neuropathic pain (DPNP)
  • Treatment of acute generalized anxiety disorder (GAD)
  • The management of fibromyalgia, with or without depression
Although the mechanism of the antidepressant action of Cymbalta in humans is not fully known, it is believed to be related to its potentiation of serotonergic and noradrenergic activity in the central nervous system.

Read more: Cymbalta® is now approved for fibromyalgia

RM Global Health has reached an agreement with the Vitafarma

  • Written by Abkhazia Institute
  • Category: FDA Alerts

RM Global Health Inc.,has announced that it has reached an agreement with the Russian Company Vitafarma to acquire all list of pharmaceutical production, including newly and highly efficient vaccine against virus Herpes simplex

Read more: RM Global Health has reached an agreement with the Vitafarma

ASA comments at FDA hearing on fospropofol

  • Written by Ramaz Mitaishvili
  • Category: FDA Alerts
The ASA submitted formal comments and testified before the Food and Drug Administration’s (FDA) Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) requesting that the labeling for fospropofol disodium injection 35 mg/ml (fospropofol) include a similar warning to that which is included on the label for propofol.

Read more: ASA comments at FDA hearing on fospropofol

Heparin Contamination Was Deliberate Act to Cut Costs?

  • Written by Sue Hughes
  • Category: FDA Alerts
Contamination of the worldwide heparin supply, which resulted in a substantial increase in adverse events and an estimated 81 deaths in the US, appears to have been a deliberate act to increase profits in Chinese workshops.

Read more: Heparin Contamination Was Deliberate Act to Cut Costs?

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