A survey of new Rx, new generic, and new OTC products
FDA has granted accelerated approval to Celgene’s Pomalyst capsules (pomalidomide), for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of the last therapy. Pomalidomide is available only through a REMS Program. (www.celgene.com)
FDA has approved Hyperion’s Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders in patients ages two years and older. Ravicti, a liquid taken three times daily with meals, helps dispose of ammonia in the body. It must be used with a protein-restricted diet and, in some cases, dietary supplements. (www.hyperiontx.com)
Supernus Pharmaceuticals has announced that Oxtellar XR tablets are now available for sale in the United States. Oxtellar XR is a novel once-daily extended release antiepileptic drug indicated for adjunctive therapy in the treatment of partial seizures in adults and in children six to 17 years of age. (www.oxtellar.com)
Noven Pharmaceuticals has announced the U.S. availability of Minivelle (estradiol transdermal system) by prescription. FDA approved Minivelle in October 2012 to treat moderate-to-severe hot flashes and night sweats. The smallest estrogen patch currently available, it has at its lowest strength nearly the same surface area as a dime. Noven offers a savings program to help reduce Minivelle co-pays for eligible patients. (www.minivelle.com)
FDA has approved three new related Takeda products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets. Alogliptin is a new active ingredient, while metformin hydrochloride and pioglitazone are already FDA-approved for management of type 2 diabetes. Nesina, Kazano, and Oseni should not be used to treat people with type 1 diabetes diabetic ketoacidosis. (www.takeda.com)
Late last year, FDA approved Ariad Pharmaceuticals’ Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), both rare blood and bone marrow diseases. Iclusig is taken once a day to block certain proteins that promote the development of cancerous cells. Iclusig can cause blood clots and liver toxicity and was approved with a boxed warning. (www.ariad.com)
Dr Reddy’s Laboratories has launched its generic finasteride tablets in the strength of 1 mg in the U.S. market following the approval of its abbreviated new drug application with 180 days of marketing exclusivity. Used for treating male pattern hair loss, the tablets are the bioequivalent generic version of Merck Sharp & Dohme Corp.’s Propecia tablets. (www.drreddys.com)
Sandoz has announced FDA approval and U.S. launch of clindamycin in 5% dextrose in minibag form, the first generic version of Cleocin Phosphate in Dextrose 5%. The product is an antibiotic indicated for the treatment of serious bacterial infections. Because this therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections for which less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections. (www.sandoz.com)
FDA has approved Novartis’ Exjade (deferasirox) to remove excess iron from the blood of 10-year-old and older patients with thalassemia, a rare genetic disorder. A companion diagnostic, FerriScan, made by Australia-based Resonance Health, also was approved. Exjade was previously approved to treat chronic iron overload due to blood transfusions in patients ages two years and older. (www. exjade.com)
Novartis has announced FDA approval of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer and progresses quickly if untreated. Gleevec, a tyrosine kinase inhibitor, blocks the proteins that promote the development of cancerous cells. Gleevec should be used in combination with chemotherapy. (www.gleevec.com)
FDA has approved the use of Roche’s Avastin (bevacizumab) for patients whose colorectal cancer has worsened despite previous treatment with the drug. The new use will allow patients first treated with Avastin plus chemotherapy to continue Avastin treatment in combination with a different chemotherapy regimen after their cancer worsens. Avastin is approved in the United States for treatment of glioblastoma and colorectal, lung, and kidney cancers. (www.avastin.com)
From Majestic Drug Co. comes a product for the almost 50% of U.S. adults who suffer from sensitive teeth. According to the company, one treatment of Senzzzzz Away  “will instantly put tooth sensitivity to sleep” for up to six full months. (www.majesticdrug.com / 800-238-0220).
AeroDesigns’ AeroShot Energy  is a powdered product for oral ingestion. It delivers 100 mg of caffeine and B vitamins and starts working right away. One AeroShot contains 100 mg of caffeine - about the amount contained in a large cup of coffee - and provides between four and six “draws.” The company estimates that each time AeroShot powder is drawn into the mouth and onto the tongue and swallowed, it delivers approximately 15-25 mg of caffeine. According to the company, the product complies with all FDA dietary supplement regulations when used correctly. (www.aeroshots.com)
Nordic Naturals has launched its new Vitamin D3 Gummies . This new product delivers a soft, chewable vitamin in wild berry flavor with 1000 IU per serving (one gummy). The vitamin D3 is sourced from cholecalciferol, the natural form of vitamin D preferred for optimal absorption. The pectin-based product is gelatin-free and does not contain artificial coloring, flavoring, or preservatives. The company also offers Vitamin D3 Vegan (1 oz liquid). (www.nordicnaturals.com)
Novartis Oncology recently launched two new patient-oriented mobile phone apps to help patients better manage their health and easily access and share important health information with their physicians, nurse practitioners, and healthcare teams. The apps are free and available through download from iTunes or the application store for Android mobile devices.
Clinical Trial Seek  is sourced from the National Institutes of Health (NIH) (clinicaltrials.gov) and helps patients and doctors quickly and easily search for cancer clinical trials as well as learn more about how clinical trials work, clinical trials in a geographic area, disease types, trial phases, eligibility requirements, and trials sponsors. Searches can be saved and e-mailed. (www.novartis.com)
Supported by six patient groups, My NET Manager offers patients with neuroendocrine tumors (NET) several tools that can help them organize information specific to their type of cancer. They can record symptoms, set medication reminders, track appointments, test results, and insurance, and share information with their healthcare teams. (www.novartis.com)
ScarAway Silicone Scar Sheets, from Mitchell-Vance Laboratories, are formulated specifically for the treatment and prevention of both hypertrophic (raised) and keloid scars, can now be found in 4,144 Rite Aid locations across the United States. Once available only through hospitals, burn centers and plastic surgeons, this professional-grade silicone sheeting enables patients to use at-home, noninvasive, drug-free scar management that shrinks, flattens, and fades scars, both old and new. According to the company, the product significantly reduces scars in 12 weeks or less. Unlike messy creams and ointments, the sheets are easy to use and won’t stain or stick to clothing. They come on flexible, breathable backing and can be cut to size to fit comfortably over a scar and under clothing. (www.myscaraway.com)
AccuDial Pharmaceutical puts a new spin on delivery of dosage-accurate children’s acetaminophen. Its patented AccuDial rotatingweight-based dosing system is designed to administer children’s OTC medications safely and effectively. As the consumer rotates the top label to display the child’s weight, dosing information is revealed from the inner label. The liquid is then poured, to the exact measurement, into the calibrated dosing device included in the medication package and administered to the child, eliminating approximation and guesswork.
AccuDial offers its Children’s Pain & Fever With Acetaminophen in five flavors: cherry, dye-free cherry, bubblegum, strawberry, and grape. They can be ordered online from Accuratedose.com, Amazon.com, Target.com, and Drugstore.com. For information on Accudial’s Spinformation rotating label technology, visit the company website. (www.accuratedose.com / 561-429-6886)