New Products

New Rx

(Image courtesy of Teva)DA has approved Teva’s beclomethasonedipropionate HFA (Qvar), with a dose counter, for the twice-daily treatment of asthma as a preventative therapy in patients five years of age and older. Qvar is an inhaled corticosteroid (ICS) recommended for long-term asthma control. (www.qvar.com)

Durata Therapeutics has announced FDA approval of dalbavancin (Dalvance) for injection to treat adults with acute bacterial skin and skin structure infections caused by Gram-positive bacteria such as Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosis group. (www.duratatherapeutics.com)

(Image courtesy of Takeda)Takeda Pharmaceuticals America has announced FDA approval of vedolizumab (Entyvio), a monoclonal antibody, designated to treat ulcerative colitis and Crohn’s disease when the patient has shown inadequate response to one or more standard therapies such as steroids, immunomodulators, or tumor necrosis factor inhibitors. FDA advises healthcare providers to monitor patients for new or worsening neurologic symptoms and plans postmarketing surveillance and adverse event reporting. (www.entyviohcp.com)

(Image courtesy of Janssen Biotech)Janssen Biotech’s siltuximab (Sylvant), an intravenous biologic administered every three weeks, has been approved by FDA to treat patients with multicentric Castleman’s disease (MCD) who do not have HIV or HHV-8 herpes. MCD is a high-morbidity blood disorder with behavior very similar to that of lymphoma, causing over-replication of white blood cells and causing infections, organ failures, and cancers. (www.sylvant.com)

FDA has approved mercaptopurine (Purixan, Nova Laboratories) 20 mg/mL oral suspension for use as part of a combination regimen to treat acute lymphoblastic leukemia (ALL). The company notes that for children whose age and weight present issues, the product is a desirable dosing alternative to the 50 mg tablet previously available. Mercaptopurine is distributed by Rare Disease Therapeutics, Nashville, Tenn. (www.purixan-us.com)

First and only: Pfizer has announced that the Orthodox Union (OU) has granted kosher certification to taliglucerase alfa (Elelyso) for injection, an enzyme replacement therapy for the long-term treatment of adults with Type 1 Gaucher disease. The product is the first prescription medication to be certified kosher by the OU. Gaucher disease affects an estimated 10,000 people worldwide. One of every 14 Ashkenazic Jews carries Type 1 Gaucher disease, so treatment options are a matter of concern to the Jewish community. (www.elelyso.com)

New generics

Pfizer subsidiary Greenstone LLC is launching rifabutin capsules 150 mg (authorized generic for Mycobutin) for prevention of Mycobacterium avium complex disease in HIV-infected patients. (http://greenstonellc.com)

Ajanta Pharma USA has launched risperidone tablets, the generic version of Risperdal, for treatment of schizophrenia and bipolar disorder. The tablets are available in formulations of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. (www.ajantapharmausa.com)

Dr. Reddy’s has announced the launch of fenofibrate capsules, USP, 43 mg and 130 mg (generic for Lupin’s Antara capsules), to treat hypercholesterolemia and mixed dyslipidemia. (www.drreddys.com)

OTC

In late May, Pfizer announced U.S. introduction of over-the-counter esomeprazole (Nexium 24HR), which the company calls “the nation’s most prescribed acid blocker available for treatment of frequent heartburn.” Pfizer acquired exclusive global OTC rights to Nexium from AstraZeneca in 2012. (www.nexium24hr.com)