New Rx, generic, indication, and OTC
Alcon, a division of Novartis, has announced FDA approval of Simbrinza Suspension, indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. Elevated IOP is the only modifiable risk factor for glaucoma. Glaucoma is a group of eye diseases that lead to progressive damage of the optic nerve and can result in gradual, irreversible loss of vision, and eventually blindness, if left untreated. Simbrinza is a fixed-dose combination of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%). It can decrease elevated IOP by 21%- 35%. In addition, it is the only fixed-dose combination therapy for glaucoma without a beta blocker available in the United States. Patients should administer one drop of Simbrinza into the affected eye(s), three times per day. (www.alcon.com).
FDA has approved Janssen’s Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetes patients with elevated blood glucose levels. Type 2 diabetes is the most common form of the disease, affecting about 24 million people and accounting for more than 90% of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage. (www.invokana.com)
FDA has approved Biogen Idec’s Tecfidera (dimethyl fumarate) delayed-release capsules for the treatment of adults with relapsing forms of multiple sclerosis (MS), including the most common form, relapsing-remitting multiple sclerosis. Joining two other approved oral disease-modifying medications for MS - Gilenya (fingolimod) and Augabio (teriflunomide), Tecfidera has been shown to significantly reduce relapses and the development of brain lesions and slow disability progression over time. Tecfidera should be started at a dose of 120 mg BID. It can be increased to 240 mg BID after 1 week at the starting dose. At present, there is no known cure for MS. (www.tecfidera.com)
Tris Pharma has announced FDA approval of Karbinal ER (carbinoxamine maleate) in extended-release oral suspension in the 4 mg/5 mL strength. The company said the drug was the first liquid, sustained-release histamine-H1 receptor blocker for seasonal and perennial allergic rhinitis in children 2 and older. The product is dosed once every 12 hours. (www.trispharma.com)
FDA has approved the 200-mg strength of Warner Chilcott’s Doryx (doxycycline hyclate) antibiotic delayed-release tablets, which the company plans to release in July. Doryx delayed-release tablets are already available in the 75-mg, 100-mg, and 150-mg strengths. (www.wcrx.com)
FDA has approved Taro Pharmaceutical Industries’ Topicort (desoximetasone) topical spray, 0.25%, a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older. According to the manufacturer, The U.S. market for corticosteroid spray is $100 million in annual sales. (www.taro.com/)
BD Rx Inc. announced in late April that FDA had approved its metoclopramide injection, USP, an antiemetic currently on the drug shortage list. The injectable may be used for treatment of symptoms associated with acute and recurrent diabetic gastric stasis; for prophylaxis of vomiting associated with emetogenic cancer chemotherapy; and for prophylaxis of postoperative nausea and vomiting in circumstances where nasogastric suction is undesirable.
This product is the second drug in the company’s recently launched line of BD Simplist generic prefilled injectable products. The first product, BD Simplist diphenhydramine hydrochloride Injection, USP, an injectable antihistamine, launched at the end of March. According to the company, the injectable treatments are designed to improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence and thus reduce the potential risk of medication errors. While traditional injections require up to 20 steps on the part of the physician, the Simplist requires about 12, in addition to featuring easy-to-read labels, bar-coding for easy identification, and individually packaged, prefilled syringes. (www.bdrxinc.com)
Lupin Pharmaceuticals Inc., has received final FDA approval for the Daysee pill (levonorgestrel and ethinyl estradiol tablets, USP, 0.15 mg / 0.03 mg and ethinyl estradiol tablets, USP, 0 receive 01 mg), a generic version of Teva’s Seasonique tablets, indicated for contraception in women.â¨The Daysee tablets are packaged in extended-cycle wallets containing 13 weeks’ worth of tablets: 84 tablets containing 0.15 mg levonorgestrel/0.03 mg ethinyl estradiol, and seven tablets of 0.01 mg ethinyl estradiol. Lupin has already begun shipping the product. (www.lupinpharmaceuticals.com)
FDA has approved Diclegis (doxylamine succinate and pyroxidine hydrochloride), from Duchesnay Inc., for the treatment of morning sickness. Diclegis is a generic version of Bendectin, a drug initially approved in 1956 and withdrawn from the market in 1983. Diclegis comes in the form of a single pill and will be available only with a prescription. Morning sickness affects a large portion of pregnant women. In most cases it can be managed through dietary measures such as snacking throughout the day and drinking ginger ale. But in rare cases, it is so severe that the woman requires hospitalization and treatment with intravenous fluids. (www.diclegis.com)
Sucampo Pharmaceuticals, Inc., and Takeda Pharmaceuticals U.S.A. have announced FDA approval of Amitiza (lubiprostone), making it the first oral treatment for opioid-induced constipation (OIC) in adults with chronic non-cancer pain. OIC is a common adverse effect of chronic opioid use. This is the third indication for Amitiza, which is also approved in the U.S. for the treatment of chronic idiopathic constipation (CIC) in adults and irritable bowel syndrome with constipation in adult women. Amitiza is a specific activator of ClC-2 chloride channels in the intestinal epithelium. Amitiza, via activation of apical ClC-2 channels in the intestinal epithelium, bypasses the antisecretory action of opiates. For OIC, 24 mcg should be taken twice daily. (www.amitizahcp.com)
Douglas Laboratories has launched Metabolic Lean, a dietary supplement for weight management. According to a company statement, the product is a special combination of ingredients that help promote lipolysis, thermogenic activity, and insulin function, and have also been shown to increase adiponectin levels, which facilitate proper fat metabolism and glucose regulation. Key ingredients include two plants, Sphaeranthus indicus and Garcinia mangostana, capsicum extract, and a chromium complex. (www.douglaslabs.com).
Recently launched, UrgentRX Fast Acting Powders are portable packets of such products as generic Benadryl, aspirin, and Pepto-Bismol that dissolve sublingually without the need for water, going to work three times faster than pills do. Each credit-card-sized, single-dose packet addresses an everyday ailment, such as aches and pains, allergies, and heartburn. There are also fast-acting powders for more serious conditions, including allergies and heart attacks. According to the manufacturer, after being on the market for only two days, UrgentRX Critical Care saved the life of a skier having a heart attack. It produced the same dramatic result for a worker in the UrgentRX factory; in the throes of a heart attack, he grabbed a packet off the line and saved his own life. These products are now carried on all American Airlines flights, by state ski patrols across the country, and in ambulances in 42 states. UrgentRX powders can be ordered online from Walgreens, Amazon, or Drugstore.com, or purchased through various national retailers (www.urgentrx.com).