New Products for Pharmacists 06-10-2015


New Rx, new generics, and new OTC

Rx Care

New drugs

Stiolto RespimatIn May, FDA simultaneously approved eluxadoline (Viberzi; Actavis) and rifaximin (Xifaxan; Valeant/Salix)to treat diarrhea-predominant irritable bowel syndrome (IBS-D). Eluxadoline combines a mu opioid receptor agonist with a delta opioid receptor antagonist. Rifaximin, already approved to treat hepatic encephalopathy and travelers’ diarrhea, is an antibiotic. ( (

See also: New Products for Pharmacists 05-10-2015

Invega TrinzaBoehringer Ingelheim has announced FDA approval of its once-daily tiotropium bromide and olodaterol inhalation spray (Stiolto Respimat) as a long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The product is not indicated to treat asthma or acute deterioration of COPD. A boxed warning cites LABA-related asthma-related death.( courtesy of Boehringer Ingelheim)

FDA has approved Janssen’s paliperidone palmitate (Invega Trinza), a long-acting three-month atypical antipsychotic for treatment of schizophrenia. Patients must first have received four months of treatment with Invega Sustenna, a once-monthly paliperidone palmitate therapy. The product was approved under priority review and is the longest-acting treatment available. A boxed warning specifies danger of death in cognitively disrupted elderly patients. ( courtesy of Janssen Pharmaceuticals)

SaxendaNovo Nordisk has announced the U.S. launch of liraglutide [rDNA origin] injection (Saxenda), the first once-daily GLP-1 receptor agonist indicated for chronic weight management in adults with obesity as an adjunct to diet and exercise. The boxed warning emphasizes the risk of thyroid C-cell tumors. ( courtesy of Novo Nordisk)

FDA has approved methylphenidate HCl extended-release (Aptensio XR; Rhodes Pharmaceuticals), a central nervous system stimulant used to treat attention deficit hyperactivity disorder. Effect of onset is one hour and duration of effect is 12 hours; approximately 40% of the active ingredient releases
immediately and approximately 60% is delivered later in the day. The product’s boxed warning highlights the possibility of abuse and dependence. (

Vernalis and Tris Pharma have received FDA approval for codeine polistirex and chlorpheniramine polistirex (Tuzistra XR), which offers adults 12-hour relief of cough. The manufacturer states that Tuzistra XR is the only codeine-based extended-release oral suspension cough-cold treatment available in the United States. (

Emergent Biosolutions has announced FDA approval of coagulation factor IX [recombinant] (Ixinity), an IV recombinant human coagulation factor IX therapeutic for control and prevention of bleeding episodes and for perioperative management in adults and children ≥12 years old with hemophilia B. (

AstraZeneca has launched naloxegol (Movantik) in the United States, described as the first once-daily oral peripherally acting mu-opioid receptor antagonist medication indicated to treat opioid-induced constipation in adults who have chronic, noncancerous pain. Product is now available. (


New generics


AripiprazoleCamber Pharmaceuticals has announced the launch of famciclovir in 125-, 250-, and 500-mg tablets. The product is generic for Novartis’ Famvir, used to treat herpes virus infections such as shingles, cold sores, and genital herpes. ( (Image courtesy of Camber Pharmaceuticals)

See also: New products for pharmacists 04-10-2015

Camber has also launched aripiprazole, the generic version of Otsuka’s Abilify, for treatment of schizophrenia, bipolar disorder, and depression. It is available in 2-,5-,10-,15-, 20-, and 30-mg tablets. ( courtesy of Camber Pharmaceuticals)

FDA has granted final approval to Glenmark’s desmopressin acetate tablets, in 0.1-mg and 0.2-mg doses, the therapeutic equivalent of Ferring Pharmceuticals’ DDAVP, 0.1 mg and 0.2 mg. Glenmark plans to commence shipping of the product immediately. (

Teva has announced U.S. launch of Argatroban Injection in 0.9% sodium chloride, 250 mg/250 mL, for intravenous infusion only. The anticoagulant is used to prevent or treat blood clots in adult patients who have heparin-induced thrombocytopenia. Teva is also reintroducing Ondansetron Injection USP 40 mg/20 mL and Mesna Injection. (

Mylan has launched what it describes as the first and only fentanyl transdermal system available in “intermediate” dosage strengths of 37.5 mcg/hr, 62.5 mcg/hr, and 87.5 mcg/hr, indicated for the management in opioid-tolerant patients of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Product carries a boxed warning advising of numerous consequences. Fentanyl is the generic version of Johnson & Johnson’s Duragesic. (


DRx Noze

AZO Yeast PlusFor nosebleed sufferers everywhere, relief is now available in the form of DRxNoze from ByzMed LLC, developed by Wisconsin pharmacist Greg Dockter. Said to stop nosebleeds within a minute, the homeopathic product, a gel applied by swab at the first sign of a bleed, uses a combination of natural active ingredients to control the mucus balance on the nasal membrane, shutting down blood flow to the area. The product is currently available through the website and ( (Image courtesy of Byzmed LLC)

New AZO Yeast Plus is formulated to provide symptom relief for vaginal and yeast infections. Three homeopathic tablets a day work with the body to help relieve the four most bothersome symptoms of itching, burning, occasional odor, and discharge. One tablet a day can be taken for occasional support. Product is available through major retailers nationwide. ( (Image courtesy of i-Health Inc.)

DL VIsion SuiteDouglas Laboratories has launched a new line of vision health supplements: Ultra Preventive Vision, a comprehensive multivitamin/mineral formula; Macu-Support, which supplies a balanced spectrum of key antioxidants; and Eye Moisture Support, a unique dietary supplement featuring fish oil, organic borage seed oil, and astaxanthin. Ordering information is available at the website. ( (Image courtesy of Douglas Laboratories)

The Lindi Skin brand claims to be “the first complete skincare line designed specifically for the unique needs of people undergoing cancer treatment” such as radiation and chemotherapy. Products for the face include a face serum, face moisturizer, face wash, eye hydrator, and lip balm. Products designed to relieve dry, itchy skin include body lotion, skin balm, and body wash. Company literature states that these products are also recommended for post-peel and laser treatments. (

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