New Products for pharmacists 03-10-2015

March 10, 2015

New Rx, new generics, new OTC, new devices

Rx Care

New drugs

FDA has approved Sanofi’s insulin glargine [rDNA origin] injection, 300 U/mL (Toujeo), a once-daily, long-acting basal insulin for treatment of adults with both type 1 and type 2 diabetes. With Sanofi’s popular diabetes drug Lantus about to go off patent, the company is launching this similar but more potent product; Toujeo has three times the insulin glargine contained in Lantus, and is designed for more gradual release, resulting in fewer episodes of hypoglycemia. (www.sanofi.com)

FDA has approved ceftazidime-avibactam (Avycaz), a new drug combination from Actavis, indicated to combat several antibiotic-resistant
infections, including certain abdominal infections when used with another drug, and for complicated urinary tract infections that have few other options. Forest Pharmaceuticals (acquired by Actavis last year) will distribute the product. (www.frx.com)

FDA has approved lenvatinib (Lenvima; Eisai) for the treatment of patients with progressive, differentiated thyroid cancer for whom radioactive iodine therapy was ineffective. (www.lenvima.com)

Pfizer announced that FDA awarded accelerated approval and breakthrough therapy designation to palbociclib (Ibrance) to treat advanced (metastatic) breast cancer. (www.ibrance.com)

Novartis has announced FDA approval of panobinostat (Farydak) for treatment of multiple myeloma, a form of blood cancer. FDA gave Farydak both priority review and orphan product designation. (www.farydak.com)

FDA has approved empagliflozin/linagliptin (Glyxambi), a first-in-class Boehringer Ingelheim/Eli Lilly product combining drugs from each that treat type 2 diabetes. (www.glyxambi.com)

See also: New Products for Pharmacists 02-10-2015

Now available

Recent weeks have seen numerous announcements of new product availability in the United States. Among them:

Hydrocodone bitartrate extended-release tablets CII (Hysingla ER; Purdue Pharma), formulated as a once-daily, abuse-deterrent hydrocodone product, are now commercially available. (www.purduepharma.com)

See also: Product updates for pharmacists 01-10-2015

Edoxaban (Savaysa; Daiichi Sankyo), an oral, once-daily selective factor Xa-inhibitor, indicated to reduce risk of stroke and systemic embolism, is now commercially available in U.S. pharmacies. (www.savaysa.com)

Tiotropium bromide inhalation spray (Spiriva Respimat; Boehringer Ingelheim), a once-daily maintenance treatment for bronchospasm associated with COPD, is now available by prescription through U.S. retail pharmacies. (www.spiriva.com) (Image courtesy of Boehringer Ingelheim)

Suvorexant (Belsomra; Merck), for the treatment of insomnia in adults who have difficulty falling asleep and/or staying asleep, is now available at pharmacies in the United States. (www.belsomra.com)

• Insulin human inhalation powder (Afrezza; Sanofi/Mannkind), the only inhaled insulin on the market, is now available by prescription in U.S. retail pharmacies. (www.afrezza.com)

Fluticasone furoate inhalation powder (Arnuity Ellipta; GlaxoSmithKline [GSK]), a once-daily inhaled corticosteroid asthma maintenance treatment, is now available in U.S. retail pharmacies. (www.gsksource.com)

Umeclidinium (Incruse Ellipta; GSK), a long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, is now available in U.S. retail pharmacies. (www.gsksource.com) (Image courtesy of GlaxoSmithKline)

Ivermectin cream 1% (Soolantra Cream; Galderma), the first once-daily prescription topical rosacea treatment in nearly a decade, is now available in retail pharmacies across the country. (www.soolantra.com) (Image courtesy of Galderma)

Orlistat (Alli, GSK), an OTC weight-loss aid, has returned to retail shelves in newly fortified, “tamper-evident” packaging. (www.myalli.com)

Fluticasone propionate nasal spray (Flonase Allergy Relief; GSK) is now available, at full prescription strength, on OTC shelves at drugstores, groceries, and mass retailers. (www.flonase.com)

 

New generics

In February Teva launched enoxaparin sodium injection, generic for Sanofi’s Lovenox, used to prevent deep vein thrombosis, in seven dosage strengths. (www.tevapharm.com)

Teva has also launched nafcillin for injection USP, a generic-only product to treat bacterial infections, and is reintroducing into the market leucovorin calcium for injection (100 mg/vial), for use as an antidote to folic acid antagonists; methylprednisolone acetate injectable suspension, USP (40 mg/mL), an anti-inflammatory glucocorticoid; and ondansetron injection, USP (2 mg/mL), used to prevent nausea and vomiting associated with cancer treatment. (www.tevapharm.com) (Image courtesy of Teva Pharmaceuticals)

Teva also has introduced a 10-mg strength for dexmethylphenidate hydrochloride extended-release capsules, CII, the AB-rated bioequivalent to Novartis’ Focalin XR Extended-Release Capsules, CII, for treatment of ADHD. Teva now offers dexmethylphenidate HCl ER in 5-mg, 10-mg, 15-mg, 30-mg, and 40-mg strengths. (www.tevapharm.com)

FDA has approved Lupin’s bimatoprost ophthalmic solution, 0.03%, generic for Allergan’s Lumigan ophthalmic solution. (www.lupin.com)

Mylan Inc. has announced the U.S. launch of lamivudine tablets 100 mg, generic for GSK’s Epivir-HBV, a hepatitis B medication. (www.mylan.com)

Prasco and Takeda have entered into a distribution-and-supply agreement for the U.S. distribution rights to colchicine tablets, USP, the authorized generic version of Takeda’s Colcrys tablets for treatment of gout. (www.prasco.com) (Image courtesy of Prasco)

Sandoz has announced the launch of telmisartan tablets, generic for Boehringer Ingelheim’s Micardis, indicated for the treatment of hypertension, in strengths of 20, 40, and 80 mg. (www.sandoz.com)

Camber has launched rizatriptan benzoate, in 5-mg and 10-mg tablets. This product is Camber’s generic version of Merck’s Maxalt tablets, a treatment for migraine headaches. (www.camberpharma.com) (Image courtesy of Camber Pharmaceuticals)

FDA has approved Actavis’ buprenorphine sublingual tablets, 2 mg and 8 mg, the generic version of Reckitt Benckiser’s Subutex, for the treatment of opioid dependence. The product will commence shipment shortly.

New device

For patients who need help remembering to take their meds, Remind-a-Cap offers an ergonomically designed pill-bottle cap that, without need of batteries or programming, can be set for the next dose; the dial on the cap turns with a click to reveal the day of week and the time for the next dose (a.m. or p.m.). This product was recognized as the top Innovative Branded Technology in the recently announced 2014 PM360 Pharma Choice Awards. (www.remindacap.com)  (Image courtesy of Remind-a-Cap)