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.

May 05, 2005

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.

April 08, 2005

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.

March 03, 2005

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.

February 07, 2005

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.

January 20, 2005

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.

December 16, 2004

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.

November 23, 2004

October 2004 This month's column reviews FDA's new product approvals and labeling changes for Cymbalta, Clarinex, Saizen, and Palladone.

October 12, 2004

September 2004 New FDA approvals include the SSNRI Cymbalta (duloxetine), and new indications include Topamax, Alimta, Taxotere, Geodon, Geodon, Adderall XR, Vioxx, and Humira.

September 16, 2004

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.

August 18, 2004

July 2004 The FDA has approved labeling changes for the antidepressants Effexor and Effexor XR (venlafaxine), Paxil (paroxetine), Serzone (nefazodone), and Wellbutrin (bupropion hydrochloride).

July 14, 2004

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.

June 16, 2004

May 2004 Read about the latest round of FDA new product approvals and labeling changes.

June 04, 2004

March 2004 Two new monoclonal antibodies approved for cancer treatment -- bevacizumab and cetuximab.

April 06, 2004

February 2004 Novel product approvals slow down, and the FDA responds with a new course for change.

February 13, 2004

Food and Drug Administration Approvals, December 2003 A third ED drug was approved by the FDA -- what makes this one different?

December 15, 2003

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.

January 26, 2004

November 2003 Radiogardase and Namenda are among the newly approved agents discussed in this month's column.

November 13, 2003

Food and Drug Administration Approvals -- October 2003 Read about the novel antibiotic approved by the FDA along with other recent drug and biologic approvals.

October 22, 2003

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.

August 29, 2003