New Products for Pharmacists 02-10-2016


New Rx, new indications, new formulations, and new generics


New drugs

Late in January, FDA approved Merck’s once-a-day combo pill elbasvir/grazoprevir (Zepatier), to be used with or without ribavirin for treatment of chronic hepatitis C (HCV) genotypes 1 and 4. Zepatier was granted breakthrough-therapy designation for treatment of chronic HCV genotype 1 infection in hemodialysis patients with end-stage renal disease and for treatment of chronic HCV genotype 4 infection. The most common side effects were fatigue, headache, and nausea when taken without ribavirin and anemia and headache with ribavirin. This product carries a warning about elevated liver enzymes. Liver-related blood tests should be performed before therapy begins and continue through treatment. Patients with moderate or severe liver impairment should not take this drug.  (

TresibaToward the end of January, Novo Nordisk announced the nationwide availability of its newest insulin injection, insulin degludec injection 200 units/mL  (Tresiba), approved by FDA in September 2015 to improve glycemic control in adults with diabetes. Tresiba will be available in the FlexTouch pen device in 100 units/mL or 200 units/mL. It is designed to last at least 42 hours after once-a-day injection, enabling patients to schedule doses at their convenience. Novo Nordisk is offering a Tresiba Instant Savings Card that can lower co-pays to as little as $15 for 24 months for qualifying patients with commercial insurance.  ( (Product image courtesy of Novo Nordisk)

Eisai’s chemotherapy drug eribulin mesylate (Halaven) was approved in late January. Described as the first drug to show survival benefit in liposarcoma, a soft-tissue sarcoma appearing in fat cells, it is indicated to treat unresectable or metastatic conditions in patients who have already been treated with an anthracycline drug. In clinical trials, this therapy extended survival an additional seven months beyond the comparative treatment. Halaven was given orphan drug status and priority review. (

New Indications

CosentyxFDA has approved two new indications for Novartis’ secukinumab  (Cosentyx), a human interleukin-17A antagonist first approved in January 2015 for treatment of adult patients with moderate-to severe-plaque psoriasis. The new indications are for treatment of adult patients with active ankylosing spondylitis and active psoriatic arthritis. Cosentyx is available in a single-use pen, prefilled syringes, and vials of lyophilized powder for subcutaneous injection. A Medication Guide accompanies this product. The Cosentyx Connect Personal Support Program provides assistance to eligible patients experiencing financial hardship. ( image courtesy of Novartis)

BotoxAllergan has announced recent FDA approval of onabotulinumtoxinA injection (Botox) to treat ankle and toe spasticity in adult stroke patients. Botox was first approved in 2010 for treatment of spastic muscle groups in the elbow, wrist, fingers, and in April 2015 for treatment of two thumb muscles. A boxed warning cites problems with swallowing, speaking, or breathing, and spread of toxin effects beyond the injection site. It also carries a Medication Guide. ( (Product image courtesy of Allergan)


New Formulations

Impax Laboratories has announced FDA approval of its chewable 100-mg tablet formulation of the anthelmintic
(Emverm) for treatment of pinworm, whipworm, common roundworm, common hookworm, and American

Dexilant Solutabhookworm. The product is said to have a clinical cure rate of 95%. Organ system functions, including hematopoietic and hepatic, should be assessed periodically during prolonged therapy. Release is scheduled for the second quarter of 2016. (

FDA has approved Takeda’s Dexilant SoluTab, a delayed-release orally disintegrating dexlansoprazole tablet indicated to treat heartburn associated with gastroesophageal reflux disease. Dexilant SoluTab is a proton pump inhibitor (PPI) designed to provide two separate releases of medication with its dual delayed-release (DDR) technology. Dexilant is also available in 30-mg and 60-mg delayed-release capsules. ( image courstesy of Takeda)


New Generics

FDA has approved Neos Therapeutics’ once-daily Adzenys XR-ODT, the first and only orally disintegrating extended-release tablet, for treatment of ADHD in patients six years of age and older. Bioequivalent to Shire’s amphetamine Adderall XR, the product will be available in six dosage strengths of 5, 10, 15, 20, 25, and 30 mg. A boxed warning cites high potential for abuse and dependence. (

In January, FDA approved Aurobindo’s norethindrone acetate tablets 5 mg, a generic equivalent of Duramed Pharmaceuticals’ Aygestin tablets, indicated to treat secondary amenorrhea, endometriosis, and abnormal uterine bleeding. (

In the same week in January, FDA approved Aurobindo’s famotidine tablets 20 mg and 40 mg, a generic version of Valeant’s Pepcid tablets, used to treat an active duodenal ulcer, an active benign gastric ulcer, and gastroesophageal reflux disease (GERD). It is also is used as maintenance therapy for duodenal ulcer patients after an active ulcer heals and as treatment of certain other hypersecretory conditions. (

FDA also has approved Aurobindo’s paricalcitol capsules, described as bioequivalent and therapeutically equivalent to Abbvie’s Zemplar capsules, used to treat high levels of parathyroid hormone in certain patients with chronic kidney disease. The drug will be available in dosage strengths of 1, 2, and 4 mcg. (

Greenstone has launched colestipol hydrochloride granules for oral suspension, its authorized generic version of Pfizer’s Colestid, for treatment of high cholesterol. The product will be available in cartons containing 30 5-g foils, 90 5-g foils, and in 500-g bottles that come with a scoop. (

Greenstone LinezolidGreenstone also has launched linezolid tablets 600 mg, its authorized generic version of Pfizer’s Zyvox. The drug is indicated to treat certain infections caused by susceptible Gram-positive bacteria in adults and children. ( (Product image courtesy of Greenstone)

Mylan too is launching linezolid tablets in the 600-mg strength, to treat bacterial infections. (

Mylan also is launching felbamate tablets 400 mg and 600 mg, generic for Meda’s Felbatol, indicated to treat seizures. (

Lupin has launched its norgestimate/ethinyl estradiol tablets (Tri-Lo-Marzia), generic for Janssen’s Ortho Tri-Cyclen Lo contraceptive product. (

Teva has launched Tri-Lo-Sprintec, its own generic norgestimate/ethinyl estradiol version of Janssen’s Ortho Tri-Cyclen Lo. (

Dr. Reddy’s has announced the U.S. relaunch of its esomeprazole magnesium delayed-release capsules, generic for AstraZeneca’s Nexium delayed-release capsules for treatment of GERD and ulcers. The relaunch is due to a change in capsule color. (

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