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New Rx, OTC, and generics (September 2010)


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

Key Points

New drugs

Purdue Pharma has announced FDA approval of Butrans (buprenorphine) Transdermal System CIII for the management of moderate-to-severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Delivering continuous analgesic through one patch for 7 days, Butrans is available in 3 strengths: 5, 10, and 20 mcg/hour. ( http://www.Butrans.com/)

Xanodyne has added Duet DHA Complete to its Duet prenatal vitamin line. The once-daily product includes 18 essential vitamins and minerals in an enteric-coated tablet plus 300 mg of omega-3 fatty acids in a softgel capsule. ( http://www.duetdha.com/ 877-926-6396)

Fera has made available Neptazane (methazolamide) tablets for the treatment of ocular conditions that may benefit from lowered intraocular pressure, such as chronic open-angle glaucoma and secondary glaucoma, as well as preoperative acute angle-closure glaucoma. Neptazane is available in 25-mg and 50-mg dosage strengths. ( http://www.ferapharma.com/ 414-434-6604)

New generics

FDA has granted E. Fougera first generic approval for prescription Adapalene Cream 0.1% (generically equivalent to Galderma's Differin). The AB-rated product is indicated for the treatment of acne vulgaris. ( http://www.fougera.com/ 800-645-9833)

FDA has approved Sun Pharmaceutical's ANDA for generic tamsulosin 0.4 mg capsules, therapeutically equivalent to Boehringer Ingelheim's Flomax capsules 0.4 mg. and indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). ( http://www.sunpharma.com/)

FDA has granted Glenmark Generics' ANDA for theophylline extended-release tablets, the generic version of Purdue Pharmaceutical's Uniphyl. Available in 400 mg and 600 mg strengths, the product is indicated for treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases such as emphysema and chronic bronchitis. (201-684-8000)


New CryoSTAT [1]delivers prompt, soothing relief from the itching, burning, pain, and swelling caused by hemorrhoids. The cold therapy pack is surrounded by a soft, comfortable cloth. ( http://www.cryo-stat.com/)

Chloraseptic has upgraded its line of Chloraseptic Sore Throat Lozenges and has restaged its Chloraseptic Throat Spray Line. The new lozenge line features four soothing flavors - Cherry, Citrus, Honey Lemon and Green Tea; the latter two products are made with real honey. The Wild Cherry Total lozenges, available in sugar-free and regular, suppress coughs for up to 4 hours. Chloraseptic Sore Throat Sprays have been updated with a new spray nozzle and bottle. ( http://www.prestigebrandsinc.com/)

Homeolab USA has added a new homeopathic remedy to its Kids Relief line. Acetaminophen-free Kids Relief Pain & Fever [2] offers a natural, safe, and effective way to help reduce fever and relieve minor aches and pains associated with cold, flu, headache, sore throat, and toothache. The cherry-flavored liquid formula has no added sugars or dyes. ( http://www.kidsrelief.com/)

GlaxoSmithKline has launched a new line of zinc-free Super Poligrip [3] products. Clinically proven to improve stability, retention, and bite force, Super Poligrip helps denture wearers eat foods they otherwise would have avoided, and protects against gum irritation and pain. ( http://www.mypolicare.com/)

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