New Products: Rx, OTC, generics (June 2009) - - ModernMedicine
New Products: Rx, OTC, generics (June 2009)

Source: Drug Topics

Key iconKey Points

  • New Rx: Benzyl Alcohol Lotion 5%, Creon Delayed-Release Capsules, Clinac BPO 7% Gel
  • New generics: Topiramate Tablets, Teva's drospirenone and ethinyl estradiol (generic version of Yaz oral contraceptive), Cefpodoxime Proxetil Tablets, Carbamazepine Extended-Release Tablets USP
  • OTC: CLearEars, Face Stick, Tums Dual Action, Triderma Cleanser for Facial Redness

RX CARE

New drugs

Sciele announced that Food and Drug Administration has approved Benzyl Alcohol Lotion 5% for the treatment of head lice (Pediculosis capitis) infestation. The prescription drug is intended for use only on the scalp and attached hair and is not approved for use in children younger than 6 months of age. According to the manufacturer, benzyl alcohol lotion 5% is the first FDA-approved head-lice treatment product using benzyl alcohol as the active ingredient. Sciele is a subsidiary of Shionogi. For more information, call 800-461-3696.

Solvay announced that the FDA has approved Creon (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency resulting from cystic fibrosis or other conditions. Creon is the first and only pancreatic enzyme product to receive FDA approval under new guidelines for the class. Full prescribing information for Creon will be distributed when the product becomes commercially available in the third quarter of 2009.

Ferndale has announced a promotion of Clinac BPO 7% Gel, a prescription-strength benzoyl peroxide topical treatment for mild-to-moderate acne. The company states that Clinac BPO 7% Gel stands out from other acne medications because of its vehicle, which contains oil-absorbing "acrysorb" technology said to trap excess sebum, leaving skin with a matte finish. For more information, call 1-877-352-6295.

New generics

Teva announced the introduction of Topiramate Tablets, AB-rated and bioequivalent to Topamax Tablets. The tablets are available in 25 mg, 50 mg, 100 mg, and 200 mg strengths, in bottle sizes of 60 and 1,000. Teva also announced that the U.S. Food and Drug Administration has granted approval for the Company's ANDA to market its generic version of Yaz, an oral contraceptive (drospirenone and ethinyl estradiol) from Bayer. For more information, call 888-838-2872.

Sandoz announced the introduction in the United States of Cefpodoxime Proxetil Tablets, a generic equivalent of Pfizer's Vantin. Cefpodoxime is a cephalosporin antibiotic indicated to treat mild-to-moderate infections (e.g., ear infections, sore throats, and sinusitis) caused by Gram-positive and Gram-negative bacteria. Sandoz is marketing the cefpodoxime tablets in 100 and 200 mg strengths, the same strengths in which Vantin is available. Visit http://www.us.sandoz.com/ for more information.

Taro reported that the Food and Drug Administration gave final approval to its ANDA for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg. Taro's carbamazepine extended-release tablets are bioequivalent to Novartis' Tegretol-XR Tablets, a prescription pharmaceutical product used for treating seizures. Visit http://www.taro.com/ for additional information.

OTC

Cirrus announced the launch of ClearEars, an addition to its line of ear-care products. The product is the first water-absorbing ear plug. Water trapped in the ears after swimming, or even bathing, can lead to swimmer's ear, a painful infection of the outer ear. ClearEars contains an FDA-approved polymer that draws water from the ears to help prevent ear infections. For more information about ClearEars, log onto http://www.clearears.com/.

Eco Lips has introduced Face Stick to protect the lips, nose, and face and ears "naturally and organically" from the harmful effects of the sun. With SPF 30, this easy-to-apply sunscreen not only blocks UV rays but also moisturizes dry skin, working to shield the body from the effects of sun, wind, dry heat, and cold. Visit http://www.ecolips.com/ for more information.

GlaxoSmithKline is introducing new Tums Dual Action. The product contains calcium carbonate and an additional antacid ingredient, magnesium hydroxide, along with 10 mg of famotidine, a safe and effective acid reducer, to help keep heartburn from coming back. The company says this results in a longer-lasting Tums product. For more information, visit http://www.tumsdualaction.com/.



TriDerma MD offers a new Cleanser for Facial Redness, designed with healing botanicals to cleanse, smooth, and balance red, sensitive skin. The cleanser uses an exclusive aloe ingredient said to offer fast, visible results, reducing redness while calming and soothing skin without irritation. Visit http://www.triderma.com/ for more information.

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