New Products for Pharmacists 04-10-2016


New Rx, new generics, new formulations, and new OTC


New drugs

Allergan and its partner Gedeon Richter have announced the U.S. availability of cariprazine (Vraylar), an oral, once-daily atypical antipsychotic approved for the treatment of acute manic or mixed episodes of biopolar 1 disorder (recommended dose range 3-6 mg/day) and schizophrenia in adults (recommended dosage 1.5-6 mg/day). Vraylar carries a boxed warning of increased mortality in elderly patients with dementia-related psychosis. (

FDA has approved Teva’s reslizumab (Cinqair) for use with other asthma medications as maintenance treatment of severe asthma in patients at least 18 years of age with a history of severe asthma attacks that their current medications have not controlled. Reslizumab is administered once-monthly by intravenous infusion in a clinical setting prepared to manage anaphylaxis. (

Eli Lilly has announced FDA approval of ixekizumab (Taltz) to treat moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. It is administered by means of autoinjectors and prefilled syringes. This product is accompanied by a Medication Guide. (

FDA has approved the first coagulation factor IX (recombinant)-albumin fusion protein (Idelvion; CSL Behring) for use in children and adults with hemophilia B, providing on-demand control and prevention of bleeding episodes, and management of perioperative bleeding. (

Boehringer Ingelheim has announced that idarucizumab (Praxbind) is now available in more than 2,200 U.S. hospitals. Approved last October, Praxbind was granted breakthrough therapy designation; it can reverse the anticoagulant effects of Pradaxa (dabigatran etexilate mesylate) in case of an emergency. Specifically, Praxbind is indicated to reverse dabigatran effects in the case of urgent surgical procedures and life-threatening or uncontrolled bleeding. To help healthcare providers and patients find institutions that stock Praxbind, BI has launched an online locator tool, available at

New generics

Camber has announced the launch of simvastatin USP, generic for Merck’s cholesterol-lowering Zocor tablets. The Camber product will be available in dosage strengths of 5, 10, 20, 40, and 80 mg. (

Amneal has announced the U.S. launch of diclofenac sodium topical gel 1%, its first-to-market generic equivalent of Endo’s Voltaren Gel, an NSAID indicated for treatment of osteoarthritic joints. (

Teva has launched budesonide inhalation suspension, 1 mg/2 mL, an inhaled corsticosteroid used for long-term control and prevention of asthma symptoms in children 12 months to eight years of age. Teva now offers bioequivalents to AstraZeneca’s Pulmicort Respules in all strengths, including 0.25 mg/2 mL, 0.5 mg/2 mL, and 1 mg/2 mL. (

Dr. Reddy’s U.S. subsidiary, Promius Pharma, has announced FDA approval of betamethasone diproprionate spray 0.05% (Sernivo Spray), its Rx topical steroid treatment for mild-to-moderate plaque psoriasis in patients at least 18 years of age. Treatment should be limited to four weeks and use should be avoided on the face, scalp, axilla, groin, or areas of skin atrophy. (

FDA has approved another Dr. Reddy’s product, sumatriptan succinate injection (Zembrace Symtouch), described as a prefilled, single-use, disposable autoinjection device, containing 3 mg of sumat riptan, to treat acute migraine episodes, with or without aura, in patients at least 18 years of age inadequately managed with existing treatment regimens. (

Teva has launched acamprosate calcium delayed-release tablets 333 mg, generic for Forest Laboratories’ Campral, used to help alcohol-dependent patients remain abstinent. Acamprosate calcium is to be used as part of a treatment program that includes counseling and support. Its use does not diminish or eliminate withdrawal symptoms. (

FDA has approved Aurobindo’s ibandronate sodium tablets 150 mg, therapeutically bioequivalent to Hoffmann-
La Roche’s Boniva, indicated to treat and prevent osteoporosis in postmenopausal women. (


New formulations

Aprecia has announced U.S. availability of its levetiracetam tablets (Spritam), a printed epilepsy treatment designed to dissolve with one sip of liquid. Available in 250-, 500-, 750-, and 1,000-mg dosage strengths, the tablets are indicated to treat partial onset seizure, myoclonic seizures, and primary generalized tonic-clonic seizures. (

FDA has approved Allergan’s dapsone gel 7.5% (Aczone), a once-daily pump-driven topical treatment of inflammatory and noninflammatory acne in patients 12 years of age and older. Availability is projected for May. (


EuroPharma’s Terry Naturally brand has launched Curamin Athletic Pain, containing curcumin, Boswellia, and enzymes and amino acids that target post-athletic pain relief and recovery. (

McNeil Consumer Healthcare has announced that the original prescription-strength Rhinocort Aqua Nasal Spray with budesonide is now available to consumers OTC as Rhinocort Allergy Spray, said to deliver 24-hour relief from nasal congestion, runny nose, and sneezing. (

Blue-Emu is launching Lidocare, the first OTC lidocaine patch (4% lidocaine), shipping soon to CVS and Walgreens. (

GlaxoSmithKline has announced the launch of its Children’s Flonase Allergy Relief (fluticasone propionate), an OTC antihistamine nasal spray approved to relieve allergy symptoms such as runny nose, sneezing, congestion, and itchy eyes in children four years of age and up. The spray blocks not one but six allergens, says GSK, including pollen, mold spores, dust mites, and pet dander. (

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