New Rx, OTC, indications, and generics (August 2009)


A survey of new Rx, new OTC, new indications, and new generics

Key Points


New drugs

United Therapeutics announced that the Food and Drug Administration (FDA) has approved Adcirca (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). Adcirca is indicated to improve exercise ability in patients with multiple forms of PAH. Visit for full patient and prescribing information, or call 800-545-5979.

The PriCara division of Ortho-McNeil-Janssen announced the launch of Nucynta (tapentadol) CII, designed for patients suffering from acute pain. Nucynta CII immediate-release tablets are indicated for the relief of moderate-to-severe acute pain in patients 18 years of age or older. This product is now available by prescription only, in 50-mg, 75-mg, and 100-mg tablets. Visit for more information.

Xanodyne has received FDA approval for Zipsor (diclofenac potassium) Liquid Filled Capsules, a new treatment option for relief of mild-to-moderate acute pain in patients 18 years of age or older. This product is the first prescription-strength nonsteroidal anti-inflammatory drug (NSAID) for oral administration available to the U.S. market in a liquid-filled soft gelatin capsule. Visit for more information.

New indication

The FDA has approved Novartis' Reclast (zoledronic acid 5 mg) Injection as the first therapy to prevent postmenopausal osteoporosis for two years with a single dose. Reclast is already approved as a once-yearly infusion for the treatment of postmenopausal osteoporosis. Go to for more information.

New generics

Amneal has received FDA approval to manufacture Prednisolone Sodium Phosphate Oral Solution in 15 mg/5 mL strength. This product is an AA-rated, therapeutically equivalent alternative to BioMarin's Orapred. Amneal will sell the oral solution in two sizes - 237 ml (8 oz) and 473 ml (16 oz). This grape-flavored solution does not require refrigeration. For more information visit

Teva announced that the FDA has granted approval for the company's abbreviated new drug application (ANDA) for Ursodiol Tablets USP, 250 mg and 500 mg. These tablets are the AB-rated generic equivalents of Axcan's Urso 250 and Urso Forte, indicated for treatment of patients with primary biliary cirrhosis. Shipment of this product has commenced. For more information, call 888-TEVA-USA.

The FDA approved Watson's generic version of the emergency contraceptive Plan B, to be marketed under the name Next Choice. The generic version will be available by prescription to women 17 years of age and younger. For more information, call 951-493-5300.


Bayer Diabetes Care announced the launch of A1CNow Selfcheck, a new A1C monitor that enables people with diabetes to check their A1C levels at home. This product, which is now available without a prescription through online pharmacies, has an easy-to-use design and provides at-home results within five minutes with lab accuracy. For more information, visit or

Bahama Bo's introduces Bahama Bo's Ocean Fresh Hand Sanitizer and Bahama Bo's Tropical Creme Hand Lotion. The small, easy-to-use bottles are portable and travel well in handbags, gym bags, or carry-on luggage. Ocean Fresh Hand Sanitizer kills 99.99 percent of germs on the hands. Tropical Creme Hand Lotion contains moisturizers and Vitamin E to keep skin smooth and hydrated. Both the hand sanitizer and the hand lotion are packaged in a versatile 1.5-oz hanging "tottle" bottle. For more information visit

Generex OTC introduces BaBoom! Energy Spray, which offers a convenient boost of energy without the extra calories of traditional energy drinks, Crave-NX 7-day Diet Aid Spray, to help dieters stick to their weight loss regimens, and Glucose RapidSpray, a dietary glucose spray that helps control blood sugar levels. For more information on these products, visit,, and

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