Name/CompanyApproval Dates and Comments

IncobotulinumtoxinA injection

Merz Aesthetics

The US FDA has approved this injectable botulinum toxin type A in July 2011 for the temporary improvement in the appearance of moderate to severe glabellar lines produced by repeated muscular action of the corrugator supercili and procerus muscles in adult patients.

Vemurafenib tablets

Zelboraf™ cobas® 4800 BRAF V600 Mutation Test

Genentech/Roche Group Plexxikon/Daiichi Sankyo Group

The US FDA approved this oral, small molecule, kinase inhibitor in August 2011 for the treatment of metastatic or unresectable melanoma. Therapy is specifically indicated for patients with BRAFV600E mutationpositive melanoma. This BRAF enzyme inhibitor was approved with a companion diagnostic called the cobas® 4800 BRAF V600 Mutation Test, which determines a patient’s eligibility for treatment. Vemurafenib blocks the function of the V600E-mutated BRAF protein. The BRAF protein regulates cell growth, but is mutated in about 50% of patients with late-stage melanoma. Safety and efficacy were established in a single international trial of 675 patients with late-stage melanoma with the BRAFV600E mutation who had not received prior therapy. Patients who received vemurafenib had a 74% reduced risk of disease progression or death compared with those on chemotherapy (dacarbazine), median progression free survival was 5.3 months vs. 1.6 months, respectively. Common reported side-effects of vemurafenib include joint pain, rash, hair loss, tiredness, sunburn or sun sensitivity, nausea, itching, or warts.

In June 2011, Roche announced that it was collaborating with Bristol-Myers Squibb to investigate combination therapy to improve outcomes with vemurafenib and ipilimumab (Yervoy™), an intravenously administered human monoclonal antibody that blocks a T-lymphocyte antigen (CTLA-4), which was FDA-approved in March 2011 for the treatment of metastatic melanoma.

Icatibant injection


Shire Human Genetic Therapies

The US FDA approved this selective B2 bradykinin receptor antagonist for the treatment of acute attacks of hereditary angioedema (HAE) in adults ≥18 years of age. Upon recognition of an HAE attack, patients may selfadminister through an injection in the abdominal area. In three clinical trials, the reported median time for onset of symptom relief was 2 hours compared with almost 20 hours with placebo. The most common reported sideeffects were injection site reactions, fever, increased liver enzymes, dizziness, and rash.

Drug News

In August 2011, the US FDA advised the public that chronic, high doses (400-800 mg/
day) of the antifungal drug fluconazole may be associated with a rare and distinct set of
birth defects in infants whose mothers received treatment during the first trimester of
pregnancy. This risk does not appear to be linked with a single, low dose of fluconazole
150 mg used to treat vaginal yeast infection (candidiasis). As a result, the pregnancy
category for fluconazole indications (other than vaginal candidiasis) has been
changed from category C to category D; single dose fluconazole 150 mg used to treat
vaginal candidiasis remains unchanged at category C. More information is available at: