New products: Rx, generic, OTC (April 2009)

April 1, 2009

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

Key Points

RX CARE

New drugs

The U.S. Food and Drug Administration (FDA) has approved Galderma's Vectical (calcitriol) Ointment 3mcg/g, a vitamin D3 product for the treatment of mild-to-moderate plaque psoriasis in adults. For more information, visit http://www.vectical.com/.

GTC and Ovation have announced FDA approval of ATryn (antithrombin [recombinant]) for the prevention of perioperative and peripartum thromboembolic events in patients with hereditary antithrombin deficiency. The companies expect ATryn to be available in the second quarter of 2009. More information about the product and full prescribing information may be found at http://www.lundbeckinc.com/.

Upsher-Smith announced its plans to market the prenatal vitamin PreNexa, a once-daily single gel capsule with 265 mg of docosahexaenoic acid (DHA) for women considering pregnancy, pregnant women, and new mothers who are breastfeeding. The DHA in PreNexa is derived from a natural plant source grown outside the ocean and has been granted "generally recognized as safe" (GRAS) status for use in infant formulas by the FDA. For additional information about PreNexa, visit http://www.prenexa.com/.

New generics

Mylan and Genpharm have received final approvals from the FDA for their abbreviated new drug applications (ANDAs) for lamotrigine tablets. Genpharm also received final FDA approval for its ANDA for a separate lamotrigine product, Lamotrigine Tablets Chewable Dispersible (CD). The ANDAs for Mylan and Genpharm were approved for the 25, 100, 150, and 200 mg strengths of the generic version of GlaxoSmithKline's Lamictal tablets. Genpharm's ANDA was approved for the 5 and 25 mg strengths of the generic version of GlaxoSmithKline's Lamictal CD tablets. These products are used for the treatment of epilepsy and for maintenance treatment of bipolar I disorder. For more information, visit the Mylan website, http://www.mylan.com/.

IMPAX has confirmed the FDA has granted final approval of the company's ANDA for minocycline HCl, in generic versions of Solodyn 45, 90, and 135 mg extended-release tablets. Medicis markets Solodyn for the treatment of moderate-to-severe acne. Find more information at http://www.impaxlabs.com/.

FDA has granted Teva final approval of the company's ANDA to market risperidone oral solution, 1 mg/mL, its generic version of Janssen's antipsychotic agent Risperdal. This product is now shipping. For more information, visit http://www.tevapharm.com/.

OTC

AirWare, maker of Brez premium nasal breathing aids, the first commercially available device for inside the nose, announced the product is available at Rite Aid drugstores and independent pharmacies. Brez is designed to reduce snoring and increase overall sleep quality for the bed partner. To learn more about Brez, visit http://www.mybrez.com/ or call 877-299-6700.

Arkray USA has announced 510(k) clearance from the FDA for the Glucocard 01-mini blood-glucose monitoring system. This system uses no coding, requires a 0.3 microliter sample size, and displays results in seven seconds. Find more information at http://www.glucocardusa.com/.

Generex has announced the release of Crave-NX 7-Day Diet Aid Spray, designed to control "junk food" cravings and help support healthy weight loss. The orange-flavored formulation is sprayed into the mouth. Each bottle of Crave-NX holds 20 servings. Visit http://www.generex.com/ or http://www.crave-nx.com/ for more information.

Kirby Lester has unveiled the KL30automated dispensing and verification system. The KL30 is designed for any retail or hospital outpatient pharmacy that processes between 100 and 1,000 prescriptions per day. The KL30 automates the dispensing of all oral solids and allows users to combine cassette and pour-through methods. Visit http://kirbylester.com/ or call 847-984-3377 for information.

Crest Whitestrips introduces new Crest Whitestrips Advanced Seal. This product contains the whitening ingredient used by dentists to remove stains on the tooth surface and below the enamel. The adhesive formulation temporarily molds the strips to users' teeth, allowing users to speak easily and even drink water. The securely fitting strips come off cleanly after whitening. Find information at http://www.whitestrips.com/.