Magazine article Drug Topics

New Products

Magazine article Drug Topics

New Products

Article excerpt

RX&OTC

RXCARE

New drags

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

AstraZeneca received approval for two new dose strengths of Atacand PkB, aimed at patients with hypertension whose condition is not optimally con- trolled by monotherapy alone. The ap- proval is for doses of 12.5 mg and 25 mg of the fixed-dose combination Atacand Plus, an angiotensin receptor blocker (candesartan cilexetil) combined with a diuretic (hydrochlorothiazide). For more information about Atacand Plus, visit www. astrazeneca.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 www.ovationpharma.com.

Upsher-Smith announced its plans to market the prenatal vitamin PreNexa [1], 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 www.prenexa.com.

New generics

Mylan and Genpharm have received final approvals from the FDA for their abbreviated new drug applications (ANDAs) for lamotriglne tablets. Genpharm also received final FDA approval for its ANDA for a separate lamotrigine product, Lamotriglne Tablets Chewable DfeperslMe (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, www. …

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