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New Drug Approvals: Generic Actos, Tradjenta Indication, CFC-Free Inhaler OTC

Several new drug approvals or indications were announced last week. Here are the ones you might be most interested in:

  • Generic Actos: The FDA approved the first generic version of Actos (pioglitazone) for glucose control in patients with type 2 diabetes.
  • New Tradjenta indication: The oral antidiabetic Tradjenta (linagliptin) can now be used as add-on therapy to insulin in patients with type 2 diabetes. Previously, it was reserved for use as an adjunct to diet and exercise, or in combination with other oral diabetes agents.
  • Over-the-counter, CFC-free asthma inhaler: Asthmanefrin — an over-the-counter, chlorofluorocarbon-free epinephrine inhaler — is now available. It will help fill the void left when Primatene Mist was discontinued in 2011 because of its CFC propellant, the manufacturer says.

FDA news release on generic Actos (Free)

Manufacturer’s news release on Tradjenta (Free)

Manufacturer’s news release on Asthmanefrin (Free PDF)

Background: Physician’s First Watch coverage of 2011 Tradjenta approval (Free)

Background: Physician’s First Watch coverage of Primatene Mist discontinuation (Free)