Food and Drug Administration Approvals

 
 
  • May 2005 The US Food and Drug Administration (FDA) has approved Baraclude (entecavir) tablets and oral solution for use in the treatment of chronic hepatitis B virus (HBV) infection in adults.
  • April 2005 The US Food and Drug Administration (FDA) has approved labeling changes for Crestor (rosuvastatin) on the basis of results of postmarketing studies in Asian-Americans.
  • March 2005 The FDA has been under increased scrutiny mainly due to numerous drug safety issues and a decrease in the approval of novel therapies.
  • February 2005 The US Food and Drug Administration (FDA) gave marketing approval for a new pulmonary agent for the treatment of pulmonary arterial hypertension, Ventavis (iloprost) Inhalation Solution.
  • January 2005 The year 2004 ended with the US FDA approval of new agents for macular degeneration, overactive bladder, pain management, pediatric leukemia, and mucositis.
  • December 2004 Among the FDA approvals reported this month: Tysabri (natalizumab) for the treatment of patients with multiple sclerosis, and Tarceva (erlotinib), for the treatment of patients with NSCLC.
  • November 2004 FDA approved 2 new hormonal agents -- Luveris (lutropin alfa), for follicular stimulation in infertile hypogonadal women, and Vantas (histrelin) Implant, for palliative treatment of prostate cancer.
  • October 2004 This month's column reviews FDA's new product approvals and labeling changes for Cymbalta, Clarinex, Saizen, and Palladone.
  • September 2004 New FDA approvals include the SSNRI Cymbalta (duloxetine), and new indications include Topamax, Alimta, Taxotere, Geodon, Geodon, Adderall XR, Vioxx, and Humira.
  • Food and Drug Administration Approvals - August 2004 This month's column reviews FDA's new product approvals and labeling changes for Alinia, Botox Cosmetic, Mobic, Aldara, and Campral.
  • July 2004 The FDA has approved labeling changes for the antidepressants Effexor and Effexor XR (venlafaxine), Paxil (paroxetine), Serzone (nefazodone), and Wellbutrin (bupropion hydrochloride).
  • June 2004 FDA approved Vidaza as an orphan drug for the treatment of myelodysplastic syndrome. Additional oncology drug approvals include new indications for Gemzar, Iressa, and Taxotere.
  • May 2004 Read about the latest round of FDA new product approvals and labeling changes.
  • March 2004 Two new monoclonal antibodies approved for cancer treatment -- bevacizumab and cetuximab.
  • February 2004 Novel product approvals slow down, and the FDA responds with a new course for change.
  • January 2004 FDA approves several new pediatric indications, including Malarone (atovaquone) for the treatment of P falciparum malaria and Xenical (orlistat) for the treatment of obesity in adolescents.
  • Food and Drug Administration Approvals, December 2003 A third ED drug was approved by the FDA -- what makes this one different?
  • November 2003 Radiogardase and Namenda are among the newly approved agents discussed in this month's column.
  • Food and Drug Administration Approvals -- October 2003 Read about the novel antibiotic approved by the FDA along with other recent drug and biologic approvals.
  • July/August 2003 Read about the FDA's approval of 2 new antiviral agents for HIV and the approval of growth hormone for a non-growth hormone deficiency.