New drugs, new generics, new app of interest to pharmacists.
FDA has approved carbidopa/levodopa enteral suspension (Duopa), AbbVie’s combination treatment for advanced Parkinson’s disease. Duopa remains effective for 16 hours, while a small portable infusion pump delivers a continuous dose straight to the small intestine. Patients can call 844-386-4968 to reach the DuoConnect support program. Some needy patients may be able to obtain Duopa at no cost. (Product image courtesy of AbbVie.) (www.abbvie.com).
FDA has approved a long-acting capsule form of carbidopa-levodopa (Rytary; Impax Laboratories) to treat Parkinson’s disease, Parkinsonism, and post-encephalitic Parkinsonism after finding a manufacturing facility inadequate and turning it down twice before. (www.rytary.com)
FDA also recently aproved a fixed-dose combination of memantine hydrochloride extended-release, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor (Namzaric; Actavis/Adamas), a new treatment for moderate-to-severe dementia in Alzheimer’s patients. This product will launch in the second quarter of the year. (www.namzaric.com)
Symplemed has announced FDA approval of perindopril arginine/amlodipine besylate tablets (Prestalia), licensed from the French company Servier, for the treatment of hypertension in patients for whom monotherapy is inadequate. This is the first fixed-dose product to combine an ACE inhibitor and a calcium channel blocker. Symplmed’s bpCareConnect program (www.bpcareconnect.com), “caps blood pressure medication costs, provides monitoring devices, offers online tracking tools, and ships directly to the patients.” (www.prestalia-us.com)
FDA has given accelerated approval to Novartis’ Meningococcal Group B Vaccine [recombinant, adsorbed]) (Bexsero), for
administration to young people between the ages of 10 and 25, to prevent meningitis B, the leading cause of bacterial meningitis in the United States. Bexsero is now licensed in 37 countries. Since its first approval in Europe, over one million doses have been distributed worldwide. (www.bexsero-us.com).
Novartis has also announced FDA approval of injectable secukinumab (Cosentyx) for treatment of moderate-to-severe plaque psoriasis. Cosentyx is the first approved human monoclonal antibody to selectively bind to IL-17A and inhibit its interaction with the IL-17 receptor that triggers the inflammatory response. Patients can call 844-267-3689 to reach the Personal Support Program. (www.cosentyx.com)
Camber has launched valsartan tablets, USP, generic for Novartis’ Diovan, in doses of 40, 80, 160, and 320 mg, used to treat high blood pressure and heart failure. (www.camberpharma.com)
Camber also launched zolmitriptan 2.5-mg and 5-mg tablets, generic for IPR’s Zomig tablets, used to treat migraine headaches. (www.camberpharma.com)
Also from Camber: pantoprazole sodium delayed-release tablets USP, the generic version of Pfizer’s Protonix, used to treat gastroesophageal reflux disease (GERD). (www.camberpharma.com)
FDA has approved Ivax/Teva’s esomeprazole, the first generic version of AstraZeneca’s Nexium, for treatment of GERD. (www.tevapharm.com)
Teva has launched linezolid injection, the AP-rated bioequivalent to Pfizer’s Zyvox Injection, used to treat pneumonia and bacterial and skin structure infections. (www.tevapharm.com)
Teva also has launched its own valsartan tablets, generic for Novartis’ Diovan. (www.tevapharm.com)
Isotretinoin use requires strict guidelines. Between March 1, 2010, and Feb. 28, 2011, over 400,000 attempts to fill isotretinoin prescriptions were denied due to failure to meet those guidelines. Promius Pharma, maker of Zenatane, has launched The Promius Promise App, to help patients comply. For information about the free download, go to http://zenatane.com.