New Products

April 15, 2013

New Rx, generics, OTC, and devices

New Products for Pharmacists

NEW Rx

Novartis announced in March that FDA has approved its TOBI Podhaler (dry tobramycin inhalation powder) 28 mg per capsule for the management of cystic fibrosis patients with Pseudomonas aeruginosa bacteria in the lungs, the leading cause of loss of lung function in CF patients. The Podhaler is portable and requires nonebulizer, refrigeration, or power source to deliver the medication. Compared dto nebulized TOBI, the Podhaler shortens treatment time by about 70%. CF affects about 30,000 U.S. children and adults with an average daily treatment burden of approximately 2 hours for CF therapies. It is not known whether TOBI Podhaler is safe and effective in patients under six years of age, in those with lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia.

 (www.novartis.com) 

In March, Galena Biopharma, announced that it has entered into an agreement with Orexo AB, an emerging specialty pharmaceutical company in Sweden, to acquire Abstral (fentanyl) Sublingual Tablets for sale and distribution in the United States. Abstral was approved in the United States in 2011 and is the first and only fentanyl sublingual tablet for the management of breakthrough cancer pain in opioid-tolerant patients. The formulation delivers the analgesic power of fentanyl in a convenient and easy-to-use sublingual tablet that dissolves under the tongue within seconds, providing rapid pain relief and predictable dosing. The product launch is expected to occur in the fourth quarther of 2013. (www.galenabiopharma.com)

FDA has approved a new pocket-sized packet option for AbbVie’s AndroGel (testosterone gel) 1.62%, a controlled substance available by prescription to treat adult males who have low or no testosterone (also known as hypogonadism). The product is a clear, unscented, quick-drying gel shown to raise testosterone levels in hypogonadal men. Patients may be prescribed 20.25 mg to 81 mg based on serum total testosterone levels and their doctor’s discretion. It is important that patients apply AndroGel 1.62% exactly as instructed by their healthcare provider. (www.androgel.com)

In February, FDA approved Shionogi’s Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause. Dyspareunia is a condition associated with declining levels of estrogen hormones during menopause. Less estrogen can make vaginal tissues thinner, drier and more fragile, resulting in pain during sexual intercourse. Osphena, a pill taken with food once daily, acts like estrogen on vaginal tissues to make them thicker and less fragile, resulting in a reduction in the amount of pain women experience with sexual intercourse. Osphena was approved with a boxed warning alerting women and health care professionals that the drug has been shown to stimulate the lining of the uterus (endometrium) and cause it to thicken. In fertile women, this thickening occurs monthly before menstruation. The boxed warning also states the incidence rates of thrombotic and hemorrhagic strokes (0.72 and 1.45 per thousand women, respectively) and the incidence rate of deep vein thrombosis (1.45 per thousand women). These rates are considered to represent low risks in contrast to the increased risks of stroke and deep vein thrombosis seen with estrogen-alone therapy. (www.osphena.com)

NEW GENERICS

In February Greenstone LLC, a U.S.-based generic pharmaceutical subsidiary of Pfizer Inc. announced the introduction of hydrocortisone tablets, USP to its generic pharmaceutical product line. The product (the generic version of Pharmacia and Upjohn’s Cortef) is offered in dosage strengths of 5 mg x 50; 10 mg x 100; 20 mg x 100. (www.greenstoneLLC.com)

In February, FDA approved Amneal’s buprenorphine HCl and naloxone HCl tablets for treating opioid addiction. Product is one of the first generic versions of Reckitt Benckiser’s Suboxone sublingual tablets for maintenance treatment of opioid drug dependence. Generic buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets are now available in 2 mg/0.5 mg and 8 mg/2 mg strengths, both in 30-count bottles. Manufacturer states that the generic product offers tremendous cost savings for both consumers and the U.S. healthcare system, while delivering the same therapeutic effect as the brand medication. (www.amneal.com)

In February, Elite Pharmaceuticals announced FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride 50 mg tablets, enabling it to begin producing and packaging the product for its partner distributor. Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid addiction. (www.elitepharma.com)

NEW OTC

Miami-based bioceutical and nutritional supplement manufacturer Scimera BioScience has announced the launch of its novel probiotic formulation, Asprega ProPac, to address the gastrointestinal side effects of antibiotic therapy, including antibiotic-associated diarrhea. Forty million patients suffer from this reaction to antibiotics. Scimera packages its probiotic in a 10-day course to be taken along with a typical 10-day course of antibiotics. (www.scimera.com)

Acura Pharmaceuticals has announced that Nexafed, which launched in December 2012, will now be stocked by the Kerr Drug chain at more than 70 locations in North Carolina. The product is a 30 mg immediate-release pseudoephedrine product that combines effective nasal-congestion relief with a unique technology that disrupts the conversion of the cold and allergy medicine into methamphetamine. Nexafed, which is available nationwide through national and regional drug wholesalers, is said to be as efficient as name-brand pseudoephedrine products and is comparably priced. (www.nexafed.com)

Rise-N-Shine LLC is promoting an all-natural supplement designed to help sleepers to awaken in the morning energized and refreshed. Taken at bedtime, Wake Up on Time is a proprietary blend of B vitamins, amino acids, guarana seed extract, and Siberian ginseng in a special delayed-release coating. Product is available at select stores across the United States and also can be ordered from product website. (www.wakeupontime.com)

NEW DEVICE

EMD Serono and Pfizer announced that FDA approved a single-use auto-injector to administer a multiple sclerosis drug. The auto-injector, Rebif Rebidose, allows patients with multiple sclerosis to self-administer the drug Rebif, a disease-modifying drug used to treat relapsing forms of multiple sclerosis. In the user trial (N=109), patients evaluated the product as “easy to use” or “very easy to use.” An estimated 400,000 people in the United States are living with MS, a chronic, inflammatory condition of the central nervous system. (www.rebif.com/Rebidose)