New Rx, indications, generics, OTC, and devices.
Astellas Pharma U.S has announced that Astagraf XL (tacrolimus extended-release capsules), approved in July, is now available in U.S. pharmacies. The first once-daily oral tacrolimus formulation available in the United States for the prophylaxis of organ rejection in patients receiving a kidney transplant, it is used with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. (www.Astellas.us)
In September, FDA approved Janssen’s Stelara (ustekinumab), alone or combined with methotrexate, to treat active psoriatic arthritis, a chronic autoimmune disease characterized by joint inflammation and psoriasis skin lesions, in patients 18 years of age or older. Stelara is the first treatment approved for psoriatic arthritis since the introduction of anti-TNF biologic products more than a decade ago. It is currently the only therapy available that targets the cytokines interleukin-12 and interleukin-23, two naturally occurring proteins that may play a role in the development of psoriatic arthritis. (http://www.stelarainfo.com) (Image courtesy of Janssen Pharmaceuticals)
FDA has approved Celgene's Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. Adenocarcinoma, a subtype of exocrine tumors, accounts for about 95% of cancers of the pancreas. Abraxane is the first new treatment approved for metastatic pancreatic cancer in nearly eight years. (www.abraxane.com) (Image courtesy of Celgene Corporation)
Allergan has received approval from FDA to market Botox Cosmetic (onabotulinumtoxinA), for an additional indication to temporarily treat moderate to severe lateral canthal lines, commonly known as “crow’s feet.” It is the first and only product of its kind approved for this indication. Botox Cosmetic was approved in the United States in 2002 for the temporary improvement of moderate to severe glabellar lines (frown lines between the brows) for patients aged 18 to 65 years. According to the manufacturer, it remains the foremost minimally invasive aesthetic medical treatment globally.
Orexo U.S. has announced that once-daily Zubsolv (buprenorphine and naloxone sublingual tablets [CIII]) is now commercially available in pharmacies across the United States. Approved by FDA in early July, Zubsolv is a maintenance treatment for people suffering from opioid dependence. The product offers higher bioavailability, resulting in a lower drug dose available for inappropriate use. Each Zubsolv tablet is wrapped in an individual blister pack, reducing chances of tampering by children. Zubsolv should be used as part of a complete treatment plan that includes counseling and psychosocial support. Orexo is also launching RISE, an around-the-clock support program designed with input from patients in recovery. (www.zubsolv.com / http://www.rise-us.com)
In late September, FDA approved Perrigo’s nitroglycerin lingual spray (generic for Arbor Pharmaceuticals’ Nitrolingual Pumpspray) in the 400-mcg-per-spray strength. The drug is used to relieve or prevent attacks of angina pectoris resulting from coronary artery disease. Perrigo was awarded 180 days of generic drug exclusivity, as it was the first company to submit an ANDA containing a paragraph IV certification. The product is shipping now. (http://www.perrigo.com) (Image courtesy of Perrigo Consumer Healthcare Products)
In mid-September, Dr. Reddy’s announced FDS approval of Azacitidine for Injection (100 mg/vial), a bioequivalent generic version of Celgene’s Vidaza (azacitidine for injection). The product, which treats patients with myelodysplastic syndromes, is available in single-use vials. The company expects to launch the product soon. (http://www.drreddys.com)
At the end of August, the third prefilled generic injectable from the BD Simplist line of BD Rx Inc., was approved, the emetic ondansetron injection, USP, 4 mg/2 mL (2 mg/mL). Used to prevent postoperative nausea and vomiting, the product is currently on the FDA drug shortage list. BD Rx also manufactures metoclopramide injection, USP, and diphenhydramine hydrochloride injection, USP. (http://bit.ly/ondansetron)
In September 2012, following reports of differences in efficacy between GlaxoSmithKline's Wellbutrin XL, indicated for the treatment of major depressive disorder (MDD), and some generic versions, FDA asked companies making generic bupropion hydrochloride extended-release tablets to conduct studies to demonstrate that their versions were as effective as the branded version.
Mylan has announced FDA approval of its supplemental Abbreviated New Drug Application, which provided bioequivalence study results for its bupropion HCl extended-release (ER) tablets USP (XL), 300 mg, the generic version of GlaxoSmithKline's Wellbutrin XL. Mylan launched its Bupropion HCl ER Tablets USP (XL), 150 mg and 300 mg, in the U.S. market in September 2010. (http://www.mylan.com)
FDA has also approved Par Pharmaceutical’s bupropion hydrochloride (HCl) extended-release tablets in the 300-mg strength. Par already markets generic bupropion in the 150-mg strength. Par also conducted a study demonstrating that its version was equivalent to GSK's. (http://www.parpharm.com)
Seen at the NACDS Total Store Expo in Las Vegas:
In September, Abbott introduced Glucerna Advance, a new shake offering people with diabetes targeted nutrition formulated to minimize blood sugar spikes while supporting heart health and the immune system. Ingredients include slowly digested carbohydrates, plant-based phytosterols and omega 3s for heart health, antioxidants for the immune system (vitamins C and E, and selenium), and chromium from chromium picolinate for carbohydrate metabolism. The product comes in chocolate and vanilla flavors. (http://glucerna.com/diabetes-shakes-advance) (Image courtesy of Abbott Laboratories)
Perrigo has received final FDA approval for bubble-gum flavored cetirizine hydrochloride oral solution USP (1 mg/mL), the store-brand equivalent to Children's Zyrtec Allergy Syrup from McNeil. Perrigo expects to begin shipments of the product during the upcoming cough/cold/flu season. The product is indicated for indoor and outdoor allergies in children 2 years of age and older. (http://www.perrigo.com)
Westport Pharmaceuticals has announced the national availability of Zephrex-D, a pseudoephedrine-based decongestant formulated to resist breakdown by meth-makers. The product's meth-resistant properties are provided by an innovative locking technology that provides 100% pseudoephedrine relief while deterring misuse of the medication. According to the Missouri Narcotics Officers Association, in eight months of test-marketing at more than 300 stores in Missouri, the nation's top meth-lab seizure state Zephrex-D was not connected with a single seizure. (www.zephrex-d.com)
FDA has approved Novo Nordisk’s Novopen Echo, which, according to the company, is the first insulin injection device for diabetes patients to combine half-unit dosing with a memory function that records the dose and time passed since the last injection. The pen will be available to patients for use with NovoLog (insulin aspart [rDNA origin] injection) PenFill cartridges. The manufacturer suggests that this product may be particularly useful to children with diabetes and their caregivers, since half-unit dose increments allow for finer adjustments that can be particularly important for children. Different removable skins will be available for a “kid-friendly customized look.” The pen will be available in the U.S. early in 2014. (http://www.nonvolog.com)