Product Updates for Pharmacists 10-10-2015

October 10, 2015

New Rx, generics, and OTC

Rx Care

New drugs

Novo Nordisk has announced FDA approval of two products for adults with type 1 and 2 diabetes mellitus. Insulin degludec injection (Tresiba) is an ultra-long-acting insulin analog. Patients with type 1 diabetes can use it with mealtime insulin; those with type 2 can use it with oral antidiabetes agents. Insulin degludec/insulin aspart injection (Ryzodeg 70/30), a combination of long-acting and rapid-acting insulin analogs, can be used once or twice daily at mealtimes, alone or with other antidiabetes agents. Both products are injected subcutaneously with prefilled FlexTouch pens. (www.tresiba.com) (www.novonordisk.com)

See also: New Products for Pharmacists 09-10-2015

FDA has approved cariprazine capsules (Vraylar; Allergan/Gedeon Richter), a once-daily oral treatment of manic or mixed episodes of bipolar disorder and schizophrenia in adults. Vraylar carries a boxed warning that cites increased mortality in elderly patients with dementia-related psychosis, for whom this product is not approved. (www.vraylar.com)

Tuzistra XRVernalis Therapeutics has launched codeine polistirex and chlorpheniramine polistirex (Tuzistra XR),the first long-acting codeine-based cough suppressant. The Schedule CIII liquid formulation is dosed every 12 hours in adults 18 years of age and older. It is not indicated for pediatric patients; a boxed warning cites death related to ultra-rapid metabolism of codeine to morphine in children. (www.vernalistherapeutics.com) (Product image courtesy of Vernalis Therapeutics)

FDA has approved rolapitant (Varubi; Tesaro) to prevent delayed-phase chemotherapy-induced nausea and vomiting in adults. Prolonged nausea and vomiting can result in weight loss, dehydration, and malnutrition in cancer patients, and lead to hospitalization. Varubi is approved for use in combination with other antiemetics associated with initial and repeat courses of cancer chemotherapy. (www.varubirx.com)

 

New biosimilar

September saw the launch of the first FDA-approved biosimilar with Sandoz’ filgrastim-sndz (Zarxio), a biosimilar analog of Amgen’s Neupogen, indicated to reduce risk of infection in certain cancer patients with low white-blood-cell counts. FDA has noted that the product is biosimilar, not interchangeable; the prescriber must be consulted before substitution can be made. “Filgrastim-sndz” will be used as a temporary place-holder name until FDA establishes a biosimilar naming convention. (www.zarxio.com)

See also: New Products for Pharmacists 09-10-2015

New formulation

Egalet Corp. has announced the U.S. launch of oxycodone HCI (Oxaydo), one of the first immediate-release oral tablets designed to discourage intranasal abuse of the drug; when crushed and snorted, the product causes nasal burning. Oxaydo is intended to manage acute and chronic moderate-to-severe pain where the use of an opioid analgesic is appropriate. (www.oxaydo.com)

 

New generics

Esomeprazole magnesium delayed-release capsulesCamber has launched esomeprazole magnesium delayed-release capsules, the generic version of AstraZeneca’s Nexium capsules, used to treat heartburn, gastroesophageal reflux disease (GERD), stomach ulcers, and a damaged esophagus. The product is available in dosages of 20 mg and 40 mg, and in 30-, 90-, and 1,000-count bottles for both strengths. (www.camberpharma.com(Product image courtesy of Camber Pharmaceuticals)

Camber also has launched valacyclovir in 500-mg tablets, generic for Glaxo-SmithKline’s Valtrex, used to treat herpes virus infections; and donepezil hydrochloride tablets USP, available in doses of 5 mg and 10 mg, and generic for Eisai’s Aricept, used to treat the symptoms of Alzheimer’s disease. (www.camberpharma.com)

Zecuity transdermal patchTeva has announced the U.S. availability of its sumatriptan iontophoretic transdermal system (Zecuity), the first and only transdermal patch system for treatment of acute migraine with or without aura in adults. The single-use patch combines sumatriptan with an electronic component that uses a mild  battery-powered current to transport drug molecules through the skin. During the product’s four-hour period of effectiveness, a microprocessor located in the patch automatically monitors absorption and adjusts the rate of drug delivery. (www.zecuity.com(Product image courtesy of Teva)

Dr. Reddy’s has launched its own esomeprazole magnesium delayed-release capsules USP, 20 mg and 40 mg, generic for AstraZeneca’s Nexium capsules, both available in a 30-count bottle. (www.drreddys.com)

Aurobindo is launching omeprazole delayed-release capsules USP, 10 mg, 20 mg, and 40 mg, therapeutically equivalent to AstraZeneca’s Prilosec, indicated for treatment of GERD and other conditions caused by excess stomach acid. (www.aurobindo.com)

FDA has approved Aurobindo’s  methadone hydrochloride tablets USP CII, 5 mg and 10 mg, therapeutically equivalent to Roxane’s Dolophine tablets CII. Methadone hydrochloride is an opioid agonist indicated for the management of severe pain for which alternative treatment options are inadequate. (www.aurobindo.com)

FDA also has approved Aurobindo’s telmisartan tablets, a generic version of Boehringer Ingelheim’s hypertension agent Micardis. The product will be available in 20-, 40-, and 80-mg tablets and is indicated to treat hypertension. (www.aurobindo.com)

Heritage Pharmaceuticals has launched calcium acetate 667-mg immediate-release capsules, the AB-rated generic equivalent to the phosphate-binding drug PhosLo (Nabi Biopharmaceuticals), indicated to reduce serum phosphorus in patients with end-stage renal disease. (www.heritagepharma.com)

 

 

OTC

Fluwar is an alcohol-free antibacterial hand sanitizer available in gel and wipes from DJO Global, a provider of sports medicine products. The sanitizer contains aloe and vitamin E in addition to benzalkonium chloride, its active ingredient. The company states that unlike alcohol-based sanitizers, which dry out the skin and require repeated applications, this product can last “for hours vs. seconds” and has a moisturizing effect. (www.djoglobal.com)

Heliocare Ultra Dietary SupplementHeliocare Ultra Dietary Supplement blends antioxidants, vitamin C, and pomegranate extract in a vegetarian formula designed to help support the skin’s ability to protect itself against sun-related effects and aging. Its extra strength formula contains twice as many antioxidants as the original Heliocareproduct. (www.heliocare.com(Product image courtesy of Ferndale Healthcare)

CeraVe BabyValeant’s CeraVe Baby line has launched two new products: CeraVe Baby Moisturizing Cream and CeraVe Baby Sunscreen Lotion SPF45, designed to help protect and maintain a baby’s delicate skin. (www.cerave.com(Product images courtesy of Valeant)

Vamousse Lice Defense ShampooVamousse Lice Treatment and Vamousse Lice Defense [6] by TyraTech are safe, nontoxic, pesticide-free solutions to the growing problem of head lice among kids.  Vamousse kills lice without the use of the pesticides to which some strains of “super lice” are becoming increasingly resistant. Lice Treatment kills lice and their eggs in one treatment. The shampoo is designed to defend against lice when used for 10-14 days following a potential exposure. (www.vamousselice.com)