New Products for pharmacists 10-10-2014

October 10, 2014

New Rx, indications, generics, and OTC products

New Rx

FDA has approved dulaglutide (Trulicity; Eli Lilly), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes, which affects about 26 million people and accounts for more than 90% of U.S. diabetes cases. A glucagon-like peptide-1 (GLP-1) receptor agonist, dulaglutide for injection is a new treatment option that can be used alone or added to existing regimens to control patients’ blood-sugar levels. It is not indicated for patients with type 1 diabetes or diabetic ketoacidosis, or as first-line therapy for patients who cannot be managed with diet and exercise. A boxed warning notes tumors of the thyroid gland. Post-marketing studies will be required, as well as a REMS to warn healthcare providers about serious risks. (http://www.trulicity.com(Trulicity image courtesy of Eli Lilly)

Genzyme has announced FDA approval of eliglustat (Cerdelga), a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1. Gaucher disease can cause severe and debilitating symptoms that include enlargement of the liver and spleen, various forms of bone disease, easy bruising, and anemia. FDA awarded eliglustat capsules orphan drug status as this product represents a new treatment option for a rare condition - estimates put type 1 U.S. patients at about 6,000. (http://www.cerdelga.com)

ViiV Healthcare has announced FDA approval of the fixed-dose combination of abacavir 600 mg, dolutegravir 50 mg, and lamivudine 300 mg tablets (Triumeq) for treatment of HIV-1 infection, providing patients with the first single-pill option containing dolutegravir. If patients have shown resistance to any of the ingredients, the product should not be used alone. All patients should be screened for the presence of the HLA-B*5701 allele; those who carry it are not candidates for this therapy. A boxed warning notes risk of hypersensitivity reactions, lactic acidosis, and severe hepatomegaly, and exacerbations of hepatitis B. (us.triumeq.com)

 

New Indications

Pfizer and Protalix Biotherapeutics have announced FDA approval of a pediatric indication for taliglucerase alfa (Elelyso), for injection in the treatment of type 1 Gaucher Disease. Of three degrees of severity, Gaucher type 1 is found at a higher frequency among individuals who are of Ashkenazi Jewish ancestry. Elelyso recently received kosher certification by the Orthodox Union. (http://www.elelyso.com(Elelyso image courtesy of Pfizer/Protalix Biotherapeutics)

GlaxoSmithKline has received FDA approval of an additional indication for eltrombopag (Promacta). This is a new first-in-class treatment option for use with patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. Eltrombopag is also indicated for the treatment of patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy and patients with chronic hepatitis C whose degree of ITP prevents the initiation or maintenance of interferon-based therapy. Full revised prescribing information, including a boxed warning of risk to liver function, will be available at http://bit.ly/promacta(http://www.promacta.com(Promacta image courtesy of GlaxoSmithKline)

Biogen Idec has announced FDA approval of peginterferon beta-1a (Plegridy), a twice-monthly subcutaneous injection that patients can administer themselves. Reports say this is the latest version of Avonex, the company’s once-weekly interferon beta treatment for patients with relapsing forms of multiple sclerosis. (http://www.plegridy.com)

New Generic

Teva has announced the U.S. launch of entecavir tablets, 0.5 mg and 1mg, its generic equivalent to Bristol-Myers Squibb’s Baraclude tablets for treatment of chronic hepatitis B. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. (http://www.teva.com(Entecavir image courtesy of Teva)

 

New OTC

Bee Bald has launched Smooth Plus, its daily moisturizer with broad-spectrum SPF 30 sunscreen for men and a “TSA-ready” Five-Piece Travel Kit. Other items in this all-natural product line for men include Clean (a daily cleanser), Scrub (a pre-shave exfoliating scrub), Shave (a premium shaving cream), Heal (a post-shave balm), Smooth (a daily moisturizer) and two types of Refresh Wipes (30 scented cleansing wipes). (http://www.beebald.com(Product image courtesy of Bee Bald)

Pure Encapsulations has launched ProbioMood, the latest in its probiotic line. Intended to support emotional well-being and lessen occasional stress, the product comes in single-serving stick packs blending 3 billion CFU of Lactobacillus helveticus and Bifidobacteriumlongum per pack. (www.pureencapsulations.com(ProbioMood image courtesy of Pure Encapsulations)

Zarbee’s Naturals has launched an immune support line for children and teenagers. These products include Mighty Bee Immune Support gummies that are free of animal by-products and safe for kids two years of age and up; Daily Bee Immune Support gummies formulated for everyday use by children four years old and up; Baby Immune Support + Vitamins, said to be the only immune support product on the market for babies as young as 2 months; and Elderberry Immune Support gummies for teens, designed to help support the maturing immune system. (http://www.zarbees.com)

Perfecta Products has announced the launch of Zim’s Advanced Cold Sore Kit, which includes an ointment for treatment and a lip balm for maintenance. The products both use natural ingredients, including propolis.  (www.zimsusa.com(Zim's image courtesy of Perfecta Products)

Nordic Naturals has announced the launch of Ultimate Omega D3 Sport Liquid, “The first liquid omega-3 to be ‘Certified for Sport’ by NSF International.” One teaspoon of lemon-flavored liquid provides 2,900 mg of the omega-3s EPA and DHA, as well as 1,000 I.U. of natural vitamin D3. According to a company statement, this product “offers high-intensity support for heart, brain, joints, and bones - optimizing fitness performance; promotes cardiovascular and respiratory function; promotes fat metabolism and improved body composition; and may enhance endurance.” (http://www.nordicnaturals.com(Sport Liquid image courtesy of Nordic Naturals)

New device

BD has announced the retail pharmacy launch of the BD AutoShield Duo pen needle for people with diabetes. The company describes the device as “the only pen needle to feature dual front- and back-end shields that ensure the needle is never exposed,” helping users to avoid accidental needle sticks during insulin injection and needle disposal (no recapping is necessary). It is compatible with all diabetes injection pens on the market today (http://www.bd.com(Autoshield Duo image courtesy of BD)