Vivus, Inc(Mountain View, CA)
The FDA approved Qsymia (phentermine/topiramate extended-release) capsules as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 or greater or a BMI of 27 or greater with a weightrelated comorbidity. The impact of Qsymia on cardiovascular health and its effectiveness in combination with other weight loss products have not been established. Qsymia should be taken once daily in the morning, and evening dosing should be avoided to prevent insomnia.
Capsules (phentermine/ topiramate extended-release): 3.75/23 mg, 7.5/46 mg, 11.25/69 mg, and 15/92 mg
For More Information: www.qsymia.com
Onyx Pharmaceuticals, Inc (South San Francisco, CA)
The FDA granted accelerated approval of Kyprolis (carfilzomib) for Injection. Kyprolis is approved for the treatment of patients with multiple myeloma who have received at least 2 prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression within 60 days of completion of the last therapy. It is administered intravenously over 2 to 10 minutes on 2 consecutive days each week for 3 weeks, followed by a 12-day rest period.
Single-use vial for intravenous (IV) injection: 60-mg sterile lyophilized powder
For More Information: www.kyprolis.com
Genentech, a member of the Roche Group (South San Francisco, CA)
Perjeta (pertuzumab) was approved by the FDA in combination with trastuzumab and docetaxel for the treatment of patients with HER2- positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Perjeta is a HER2/neu receptor antagonist. The initial 840-mg dose is administered as a 60-minute IV infusion, followed every 3 weeks by a 420-mg dose administered as a 30-to-60-minute IV infusion. The product should not be given as an IV push or bolus.
Single use vial for IV infusion: 420 mg/14 mL
For More Information: www.perjeta.com
Gilead Sciences, Inc (Foster City, CA)
The FDA approved once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate) in combination with safer sex practices to reduce the risk of acquiring HIV-1 infection in high-risk adults. It is the first agent to be approved for HIV prevention in uninfected adults. A Risk Evaluation and Mitigation Strategy was developed as part of a comprehensive HIV-prevention strategy. Truvada was originally approved in 2004 in combination with other antiretroviral agents as a treatment for HIV-1 infection in adults.
Tablets: 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
For More Information: www.truvada.com