New products for pharmacists: Rx, OTC, and generics (April 2012)

April 15, 2012

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

RX CARE

New drugs

FDA has approved 2 new enzyme replacement drugs for patients with pancreatic deficiencies. Both products, Ultresa and Viokace, are forms of the pancreatic enzyme pancrelipase and are intended to aid food digestion in patients with conditions leading to pancreatic insufficiency. Ultresa is a delayed-release capsule and is approved to treat children and adults with cystic fibrosis or other disorders marked by insufficient release of pancreatic enzymes. Viokace is indicated for adults with chronic pancreatitis or who have undergone partial or total pancreatectomy. It is to be taken with a proton pump inhibitor. Both products are marketed by Aptalis Pharma. ( http://www.aptalispharma.com/ / 800-950-8085)

Corcept Therapeutics Inc.'s Korlym (mifepristone) received FDA approval to treat hyperglycemia in patients with Cushing's syndrome. Cushing's, which results in symptoms such as severe fatigue, high blood pressure, high blood sugar, and obesity, has no approved treatments in the United States, though the antifungal drug ketoconazole is sometimes used off-label. Korlym's approval is specifically for patients with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance and who are not candidates for surgery or who have not responded to prior surgery. Korlym will be distributed through a central pharmacy. ( http://www.korlym.com/ / 650-327-3270)

Quinnova Pharmaceuticals, Inc. has launched 2 prescription products, Atrapro Antipruritic Hydrogel and Atrapro Dermal Spray with Preservatives. Atrapro Antipruritic Hydrogel is indicated to relieve the itch, pain, and burning associated with various dermatoses, including atopic and radiation dermatitis. It is available in a 4-ounce tube. Atrapro Dermal Spray with Preservatives is indicated for the management via debridement of wounds. The spray is available in an 8-ounce spray bottle. ( http://www.quinnova.com/ / 877-660-6263)

New indications

FDA has approved Shire's prescription medication Vyvanse (lisdexamfetamine dimesylate) capsules, (CII) as a maintenance treatment for adults with attention-deficit/hyperactivity disorder (ADHD). Once-daily Vyvanse should be used as part of a total treatment program that may include counseling or other therapies. ( http://www.vyvanse.com/ / 800-828-2088)