FDA Actions in Brief July 2012


Recent FDA Approvals (through July 2012) related to (Vivus, Gilead Sciences, Orasure, Pfizer, Ferring Pharmaceuticals, Eli Lilly, Bristol-Myers Squibb, Qiagen, Astellas Pharma US, Roche Molecular Systems, Arena Pharmaceuticals, Eisai)

Phentermine and topiramate extended-release (Qsymia, Vivus) was approved as an addition to a reduced-calorie diet and exercise for chronic weight management. It is approved for use in adults with a body mass index (BMI) of 30 kg/m2 or greater (obese) or adults with a BMI of 27 kg/m2 or greater (overweight) who have at least 1 weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

Once-daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead Sciences), in combination with safer sex practices, was approved to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

First over-the-counter HIV test (OraQuick, Orasure) was approved to detect the presence of HIV in saliva collected using a mouth swab.

Sodium picosulfate, magnesium oxide, and citric acid (Prepopik, Ferring Pharmaceuticals) was approved to help cleanse the colon in adults preparing for colonoscopy.

Cetuximab (Erbitux, Eli Lilly and Bristol-Myers Squibb) in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) was approved for the first-line treatment of patients with KRAS mutation-negative (commonly known as KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use. Concurrently, the first KRAS companion diagnostic test (therascreen, Qiagen) was approved.

Mirabegron (Myrbetriq, Astellas Pharma US) was approved to treat adults with overactive bladder.

Viral-load test (COBAS AmpliPrep/COBAS TaqMan CMV Test, Roche Molecular Systems) was approved to help healthcare professionals gauge the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.

Lorcaserin (Belviq, Arena Pharmaceuticals and Eisai) was approved 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 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes).

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