New products

September 15, 2012

A survey of new Rx, new generic, and new OTC products

RX CARE

New drugs

FDA has approved Vivus Inc.'s new weight loss drug Qsymia for adults who are obese or overweight and have at least one weight-related condition such as high blood pressure, diabetes, or high cholesterol. The drug combines two older drugs long known to help with weight loss: phentermine and topiramate. Phentermine, a stimulant that suppresses the appetite, has long been used for short-term weight loss. Topiramate, an anticonvulsant marketed as Topamax, makes people feel more satiated after eating. Researchers say the innovation of Qsymia lies in targeting multiple brain signals that drive people to overeat. Qsymia is the second weight-loss drug approved by FDA in less than a month, following Arena Pharmaceutical's Belviq in late June. ( http://www.qsymia.com/ / 888-998-4887)

FDA has approved Ferring's Prepopik (sodium picosulfate, magnesium oxide, and citric acid) to help cleanse the colon in adults preparing for colonoscopy. One dose of Prepopik consists of two packets of powder, each dissolved in cold water and taken the night before colonoscopy and the morning of the procedure. If this is not possible, patients may take the doses in the afternoon and evening before the colonoscopy. Patients must consume additional fluids during and after use to reduce the risk of fluid and electrolyte imbalance. Prepopik will be available in October. ( http://www.prepopik.com/ / 973-796-1600)

FDA has approved Horizon Pharma's Rayos (prednisone) delayed-release tablets (1 mg, 2 mg, and 5 mg) to treat a broad range of diseases, including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease. ( http://www.rayosrx.com/ / 866-479-6742)

Eli Lilly and Bristol-Myers Squibb have announced that Erbitux (cetuximab) in combination with the FOLFIRI chemotherapy regimen (irinotecan, 5-fluorouracil, leucovorin) has been granted full FDA approval 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. Erbitux is not indicated for the treatment of KRAS mutation-positive colorectal cancer. Concurrently, FDA also approved the first KRAS companion diagnostic test, the therascreen KRAS diagnostic kit developed by Qiagen. ( http://www.lilly.com/ / 317-276-2000)

New indication

FDA approved Gilead Sciences' Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Taken daily, Truvada is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV infection in adults at high risk. The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older. ( http://www.truvada.com/ / 800-445-3235)

FDA has approved Novartis' Afinitor (everolimus) tablets for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ breast cancer) in combination with exemestane after failure of treatment with letrozole or anastrozole. ( http://www.afinitor.com/ / 888-669-6682)

Sanofi Pasteur has announced that Sklice (ivermectin) Lotion, 0.5% is now commercially available by prescription in U.S. pharmacies for the topical treatment of head lice infestations in patients 6 months of age and older, in the context of an overall lice management program. No nit combing is required; however, if desired, a fine-tooth comb may be used to remove dead lice and nits. Product is available only by prescription. Parents must contact their healthcare provider before going to the pharmacy. ( http://www.Sklice.com/ / 855-475-5423)