FDA Drug Approvals and Changes: July Edition

Mary L Windle, PharmD

July 24, 2014

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Author

Mary L Windle, PharmD
Editor-in-Chief
Medscape Drug Reference

References

  1. Afrezza (insulin inhaled) prescribing information. MannKind Corporation. Valencia CA, United States., June 2014
  2. Prokocimer P, et al. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial. JAMA. 2013 Feb 13;309(6):559-69.
  3. Moran GJ, et al. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis. 2014 Jun 5. pii: S1473-3099(14)70737-6.
  4. O'Connor OA, et al. Belinostat, a novel pan-histone deacetylase inhibitor (HDACi), in relapsed or refractory peripheral T-cell lymphoma (R/R PTCL): Results from the BELIEF trial (abstract 8507). Presented at the 2013 ASCO Annual Meeting. Chicago, IL. May 31-June 4, 2013.
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  8. Boyer DS, et al. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014 Jun 4.
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