Product Updates for Pharmacists 1-10-2015

January 10, 2015

New drugs, new generics, new OTC

New Products

Rx Care

New drugs

FDA was busy in December. Here are some of the approvals announced before the year ended.

Nivolumab (Opdivo; Bristol-Myers Squibb), a new treatment for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab received breakthrough therapy designation, priority review, and orphan product designation. (www.bms.com)

Peramivir (Rapivab; Biocryst Pharmaceuticals), to treat influenza in patients 18 years and older who have acute uncomplicated influenza and have shown symptoms of flu for no more than two days. Peramivir is the first neuraminidase inhibitor approved for intravenous administration and is administered as a single IV dose. (www.biocryst.com)

Ceftolozane/tazobactam (Zerbaxa; Cubist Pharmaceuticals), indicated to treat adults with complicated urinary tract infections and complicated intra-abdominal infections caused by Gram-negative bacteria. (www.cubist.com)

Ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak; AbbVie), indicated to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with cirrhosis. (www.viekira.com)

Blinatumomab (Blincyto; Amgen) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL. The first anti-CD19 drug to receive FDA approval, blinatumomab was awarded breakthrough therapy designation, priority review, and orphan product designation. This product will cost $178,000 for two rounds of treatment at $89,000 each. (www.blincytorems.com)

New generics

Dr. Reddy’s has launched valganciclovir tablets USP 450 mg, a therapeutic equivalent generic version of Genentech’s Valcyte, indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) and to prevent CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk. Boxed warning notes hematologic toxicity, carcinogenicity, teratogenicity, and impairment of fertility. (www.drreddys.com)

Heritage Pharmaceuticals has launched furosemide injection, USP, in 20 mg/2 mL, 40 mg/4 mL, and 100 mg/10 mL strengths. It is generic equivalent to Sanofi’s diuretic drug Lasix. (www.heritagepharma) 

(Image of furosemide injection, USP, courtesy of Heritage Pharmaceuticals)

 

Camber Pharmaceuticals has launched montelukast sodium tablets, generic for Merck’s Singulair, indicated to treat asthma, exercise-induced bronchoconstriction, and allergic rhinitis. (www.camberpharma.com) 

(Image of montelukast sodium tablets courtesy of Camsber Pharmaceuticals)

 

 

 

Teva has announced the launch of celexicob capsules in dosage strengths of 50 mg, 100 mg, 200 mg, and 400 mg. The product is the AB-rated bioequivalent to Pfizer’s Celebrex capsules, indicated for arthritis, acute pain, and dysmenorrhea. (www.tevapharm.com) (Image of celexicob capsules courtesy of Teva Pharmaceuticals)

 

 

Teva has also launched amlodipine/valsartan/hydrochlorothiazide tablets, the generic equivalent of Novartis’ Exforge tablets, indicated for the treatment of hypertension. (www.tevapharm.com)

Also newly launched by Teva is levalbuterol inhalation solution, USP (concentrate), the bioequivalent of Sunovion’s Xopenex, indicated to treat or prevent bronchospasm in patients four years of age and older with reversible obstructive airway disease. (www.tevapharm.com)

OTC

Dr. Reddy’s has acquired the Habitrol brand over-the-counter nicotine replacement therapy transdermal patch, from Novartis. Shipment will commence shortly. (www.drreddys.com)