New Products for Pharmacists 07-10-2016

RX CARE: New drugs

UCB has announced that its new epilepsy treatment brivaracetam (Briviact) is now available in pharmacies around the country. FDA approved it in February as adjunctive therapy to treat partial-onset seizures in patients 16 years of age and older. Product literature states that brivaracetam can be taken at therapeutic doses from day one, serving a need among epilepsy patients. (www.briviact.com)

FDA has approved Gilead’s combination drug sofosbuvir/velpatasvir (Epclusa), for adults with chronic hepatitis C virus (HCV) infection, both with and without cirrhosis. Adults with cirrhosis may receive concomitant ribavirin therapy. This product treats all six strains of HCV, including the hard-to-treat genotype 3, and has a 90% cure rate after a 12-week course. (www.gilead.com)

FDA has granted accelerated approval to obeticholic acid  (Ocaliva; Intercept Pharmaceuticals), indicated to treat primary biliary cholangitis, previously known as primary biliary cirrhosis, in combination with ursodeoxycholic acid(UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. This product will be distributed through a specialty pharmacy network. (https://ocaliva.com)

Opko Health has announced FDA approval of calcifediol (Rayaldee) extended-release capsules, indicated for secondary hyperparathyroidism associated with vitamin D insufficiency in stage 3-4 chronic kidney disease. The manufacturer says this product offers an alternative to the current standard of care - high-dose vitamin D supplementation that is not FDA-approved. U.S. launch is planned for the second half of 2016. (www.opkorenal.com)

The first U.S. cholera vaccine has been approved by FDA. Vaxchora, from PaxVax Bermuda Ltd, is formulated to prevent cholera caused by serogroup 01, for use in adults ages 18-64. The company states that a single dose of the live weakened vaccine is especially beneficial to individuals traveling to a cholera-affected region on short notice. FDA awarded this product fast-track designation, priority review status, and tropical disease priority review. (paxvax.com)

New generics

Amneal has launched its AB-rated levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg (Larissia), generic for Lutera 28, the reference listed drug for Wyeth’s discontinued Alesse brand. The combination oral contraceptive product carries a boxed warning stating that cigarette smoking increases the risk of serious cardiovascular side effects from oral- contraceptive use. (amneal.com)

FDA has approved and awarded 180 days’ marketing exclusivity to Mayne Pharma’s dofetilide, the generic version of Pfizer’s Tikosyn, in capsules of 125 mcg, 250 mcg, and 500 mcg. Dofetilide is indicated to treat atrial fibrillation and atrial flutter. FDA recently canceled the dofetilide REMS program.  This product still carries a medication guide and a boxed warning stating that patients initiating on dofetilide be hospitalized and monitored for a minimum of 3 days. (www.maynepharma.com)

Greenstone has launched its own authorized generic dofetilide in 125-mcg, 250-mcg, and 500-mcg capsules. (http://greenstonellc.com)

Mylan has announced the U.S. launch of dutasteride capsules 0.5 mg, its generic version of GlaxoSmithKline’s Avodart capsules, to treat symptomatic benign prostatic hyperplasia (BPH), reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. (www.mylan.com)