New Products

December 10, 2013

New Rx, generics, OTC, and devices

NEW Rx

GlaxoSmithKline and Theravance have announced that Breo Ellipta, the first once-daily prescription medicine for chronic obstructive pulmonary disease (COPD), is now available to U.S. pharmacies nationwide. A new treatment option for COPD patients, estimated at 27 million people in the US alone, it was approved by FDA in May. Breo Ellipta combines the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol (100/25 mcg). It is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. It is not indicated for the relief of acute bronchospasm or for the treatment of asthma. Breo Ellipta labeling includes a boxed warning and a medication guide. (us.gsk.com) (Image courtesy of GlaxoSmithKline/Theravance.)

In October, Mission Pharmacal announced the launch of Aquoral, a protective oral spray that moistens and lubricates the mouth for up to four hours. Dry mouth, or xerostomia, affects about 25 million Americans with decreased production of saliva, a condition common in older adults as well as those taking certain prescription medications. Symptoms of dry mouth include an uncomfortable dry (like cotton), sticky or burning sensation in the mouth. Dry mouth can also cause cracked lips, dry tongue, mouth sores and ulcers, mouth infections, and dental decay. Aquoral uses oxidized glycerol triesters technology, a patented plant-derived, lipid-based technology designed to function like human saliva, to form a protective barrier on the oral mucosa that lasts longer than water-based remedies. According to the manufacturer, even though patients need a prescription for Aquoral, it is a nondrug medical device that has been shown to be more effective and longer-lasting than an artificial saliva substitute. Aquoral will launch with a special patient savings card; to make the product more affordable to patients, the card will offer up to $75 savings on their first prescription and $40 on future refills, meaning that that most patients will pay no more than $25 for a six- to eight-week supply of Aquoral. (aquoral.com)

Actelion has announced that Valchlor, the first and only FDA-approved topical formulation of mechlorethamine, is now available for patients in the United States. A once-daily topical gel, the product is an alkylating drug indicated to treat patients with stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) who have received prior skin-directed therapy. An orphan drug that was acquired by Actelion in September as part of a merger with Ceptaris Therapeutics, Valchlor is priced at $2,900 per tube. Distribution in the United States is limited to Accredo Specialty Pharmacy, which contacts patients with their permission upon prescription and arranges for mail-order delivery at a time when a recipient will be available. Actelion has established Valchlor Support, an assistance program to help eligible patients successfully start and remain on Valchlor therapy. The program includes reimbursement and financial support for eligible patients, as well as disease and product information. (www.valchlor.com) (Image courtesy of Actelion)

New generics

Next month, Amneal will launch norethindrone acetate and ethinyl estradiol tablets, USP, 1 mg/20 mcg, and ferrous fumarate tablets, 75 mg, its AB-rated generic for Loestrin 24 Fe, the manufacture of which was discontinued by Warner Chilcott in July 2013 and replaced by a chewable product. Amneal’s exclusive first-to-file generic equivalent for this brand will be sold under the name Lomedia 24 Fe. Amneal wants patients to know that they will be able to swallow the pill whole just as they did with Loestrin 24 Fe. Amneal plans to sell the product to wholesalers, distributors and direct to the trade. The company expects its new generic product to be in pharmacies the first week of January 2014. (www.amneal.com(Image courtesy of Amneal)

BD Rx has announced that FDA has approved the fourth drug in the BD Simplist generic product line of prefilled injectables. Morphine sulfate injection, USP is indicated for the management of pain not responsive to non-narcotic analgesics. The product will be available in the most common strengths: 2 mg/mL, 4 mg/mL, 5mg/mL, 8 mg/mL and 10 mg/mL. Production began in November, with distribution anticipated for early 2014. The first three drugs in the series, all launched in the past year, are diphenhydramine hydrochloride injection, USP, metoclopramide injection, USP, and ondansetron injection, USP 4 mg/2 mL (2 mg/2 mL). BD Rx plans to launch up to 20 to 30 drugs in the BD Simplist prefilled injectables product line in years to come, with a focus on the therapeutic categories primarily used by clinicians in the hospital and surgical center settings, including pain management, anesthetics, cardiovascular agents and antiemetics. (www.bd.com

NEW OTC

On January 1, 2014, American MD Labs will announce the launch of HA85 PUR Relief series of professional skin formulations for patients who are undergoing or recovering from chemotherapy and radiation treatments. HA85 is the first FDA-registered topical product to address the specific skin-care needs of these patients. The product assists in the process of burn relief; hydration of dry, cracked skin; and overall wound healing. The product’s effectiveness derives from hyaluronan or hyaluronic acid, an essential polysaccharide that is one of the major components in which cells and fibrous constituents - such as collagen and elastin - are embedded in the skin. Hyaluronic acid binds 1,000 times its weight in water, which helps to control skin-tissue hydration by providing a water reservoir for the cells. HA85 also employs a natural chemical compound, allantoin, as an anti-irritant and skin protectant to help minimize damage to patients suffering from chemotherapy and radiation treatments. Allantoin also increases the water content of the extracellular matrix and promotes cell replication and wound healing from burns. The HA85 PUR Relief Professional Series will be available in both gel and spray applications. Each product produced by this brand is dermatologist-tested and -approved, backed by independent clinical studies, and avoids harsh chemicals, parabens, PEG’s, glycols, sulfates, petro-chemicals, synthetic fragrances, and artificial dyes. The products are available now through the company website; distribution will expand after the first of the year to oncology clinics, hospitals, medi-spas, pharmacies, and online. The price is $45, and one unit of product lasts about six weeks. (http://purrelief.com(Image courtesy of American MD Labs)

Boiron has added a new pediatric cough-cold item to its lineup. Children’s Chestal Cold & Cough, a multi-symptom syrup formula, targets such symptoms of the common cold as nasal and chest congestion, cough, runny or stuffy nose, sneezing and minor sore throat. Now that manufacturers of antihistamines and decongestants have relabeled their products for children four years of age and older, the company says, it provides parents with a natural alternative for children three years of age and older. (http://bit.ly/chestal)

New devices

Novo Nordisk announced in November that FDA had granted 510(k) clearance for the insulin device NovoPen Echo, the first and only pen device in the United States with half-unit dosing and a memory function that records the dose and time passed since the last injection. The company expects the pen to be particularly attractive to parents and caregivers of children with diabetes, as half-unit dose increments allow for finer adjustments, which can be particularly important for children. In addition, different removable skins will be available for a kid-friendly customized look. The pen will be available to patients for use with NovoLog (insulin aspart [rDNA origin] injection) PenFill cartridges. The pen will become available in the United States early in 2014. (www.novonordisk-us.com / www.novolog.com(Image courtesy of Novo Nordisk)