New Rx, OTC, and generics (July 2010)

July 15, 2010

A survey of new Rx, new generic, and new OTC products

Key Points

New drugs

Mission Pharmacal has launched a new prescription prenatal vitamin, Citranatal Harmony, the first once-daily prenatal vitamin with calcium citrate, to help fetal bone growth without inducing gas or bloating in pregnant women. The product also offers essential vitamins and minerals in one easy-to-take vanilla-scented gel cap. ( http://www.missionpharmacal. com/ or http://www.citranatal.com/.)

Bayer Healthcare has announced FDA approval of Natazia (estradiol valerate and estradiol valerate/dienogest tablets) for the prevention of pregnancy. Natazia is the first oral contraceptive to deliver estradiol valerate, a synthetic estrogen that converts to estradiol in a woman's body. The product should be available this summer. ( http://www. natazia.com/888-842-2937)

NeurogesX announced that its Qutenza (capsaicin) 8% patch, the first and only product containing prescription-strength capsaicin, is now available. Clinical studies have shown that a single 1-hour Qutenza application can provide 3 months of relief from pain associated with postherpetic neuralgia, the nerve pain that can occur after shingles. Locally acting and nonnarcotic, it is unlikely to cause drowsiness or interaction with other drugs. ( http://www.qutenza.com/888-968-5767)

FDA has approved Roxro Pharma's Sprix (ketorolac tromethamine nasal spray) for short-term (up to 5 days) management of acute-moderate to moderately-severe pain requiring opioid analgesia. Compared with placebo, Sprix, a prescription intranasal formulation of a nonsteroidal anti-inflammatory drug, has demonstrated a 26% to 36% reduction in morphine use by patients over a 48-hour period. ( http://www.sprix.com / 650-322-4554)

FDA has approved Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of gastric ulcers in patients using nonsteroidal anti-inflammatory drugs (NSAIDs). Vimovo is a fixed-dose combination of delayed-release enteric-coated naproxen, a pain-relieving NSAID, and immediate-release esomeprazole, a proton pump inhibitor. (800-236-9933)

New generics

Teva announced FDA approval and commercial launch of its tamsulosin hydrochloride capsules 0.4 mg (a generic version of Boehringer Ingelheim's Flomax), a product indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (215-591-8912)

Sandoz announced the U.S. introduction of valacyclovir hydrochloride (HCl) tablets, a generic equivalent of Valtrex, indicated for treatment of cold sores in adults and pediatric patients over the age of 12 and for the treatment of initial and recurrent episodes of genital herpes. ( http://www.us. sandoz.com/609-627-8500)

OTC

Barbasol introduces Pure Silk Cherry Blossom Moisturizing Shave Cream [1] for women. The product is enriched with skin-softening ingredients such as aloe to moisturize skin and help protect against nicks and cuts. ( http://www.pure-silk.com/)

From Coria comes CeraVe Facial Moisturizing Lotion AM with SPF 30 [2], a daytime moisturizing lotion for the face with broad-spectrum protection against the sun's UVB-burning and UVA-aging rays. Other additions to the CeraVe line include CeraVe Foaming Facial Cleanser for normal to oily skin and CeraVe Facial Moisturizing Lotion PM. All contain the CeraVe trademark ceramide, hyaluronic acid, and cholesterol formula. ( http://www.cerave.com/)

Organix South has launched TheraNeem Men's Lotion Face & Body Therapé [3], made with organic neem and cooling aloe vera. Packed with antioxidants and essential fatty acids, the product has a woodsy aroma and can double as an after-shave lotion. (info@organixsouth.com/888-989-6336)