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

May 1, 2009

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

Key Points

RX CARE

New drugs

Coria, the newly expanded dermatology division of Valeant, announced the launch of Acanya Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%), indicated for the once-daily treatment of acne vulgaris in patients 12 years and older. Acanya Gel, a fixed combination of antibiotic and benzoyl peroxide (BPO) medication, is approved by the Food and Drug Administration for the once-daily treatment of both noninflammatory and inflammatory acne lesions. The gel was optimized to provide enhanced bioavailability of BPO, creating a product the company says is effective and well tolerated. For more information, visit http://www.corialabs.com/.

Fleming launched ProBarimin QT, for patients who have undergone weight-loss surgery and risk developing vitamin and mineral deficiencies because of post-surgery diet restrictions. Formulated with the help of bariatric clinic professionals, ProBarimin QT, a prescription-only vitamin supplement, offers an alternative for safe daily nutritional supplementation. This product quickly dissolves in the mouth without water (helpful for those facing post-surgery liquid-intake restrictions), contains no sugar, and has a pleasant fruit flavor. To learn more, visit http://www.flemingpharma.com/.

New indications

Forest announced the FDA approved its New Drug Application (NDA) for Lexapro (escitalopram oxalate) for the acute and maintenance treatment of major depressive disorder (MDD) in adolescents, 12 to 17 years of age. Lexapro is only the second antidepressant to be approved for the treatment of MDD in adolescents, a condition that affects approximately 2 million adolescents in the United States. To learn more, visit http://www.frx.com/.

Eli Lilly announced the FDA has approved a new indication for Symbyax (olanzapine and fluoxetine HCl capsules). Symbyax is the first drug approved by the FDA for the acute treatment of treatment-resistant depression (TRD). The new Symbyax TRD indication is for acute treatment of adult patients with MDD who have not responded to two separate trials of different antidepressants of adequate dose and duration in their current episode. For full prescribing information, including boxed warnings, go to http://www.symbyax.com/ and http://www.prozac.com/.

New generics

Zydus announced that it has received final FDA approval for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg. Topiramate tablets are the generic version of Ortho-McNeil-Janssen's Topamax Tablets. For more information, visit http://www.zydususa.com/.

Ranbaxy announced the FDA has approved its ANDA to market and manufacture Ramipril Capsules 5 mg and 10 mg. The FDA had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference-listed drug, Altace, by King. Visit http://www.ranbaxy.com/ for more information.

Teva announced the FDA granted final approval of its ANDA to market Minocycline HCl Capsules, its generic version of Medicis' acne treatment Solodyn Extended-Release Tablets, 45 mg, 90 mg, and 135 mg. Contact http://www.tevapharm.com/ for more information.

Ranbaxy announced that it has received an approval from the FDA for its ANDA for Quinapril + HCTZ Tablets (quinapril hydrochloride and hydrochlorothiazide), 10 mg/12.5 mg, 20 mg/12.5 mg, and 20mg/25mg. The FDA determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference-listed drug, Pfizer's Accuretic Tablets. For more information visit http://www.ranbaxy.com/.

OTC

Procter & Gamble's probiotic supplement, Align, is now available in select retail stores and pharmacies as well as online ( http://www.aligngi.com/) for people who suffer from episodic digestive upsets such as constipation, diarrhea, urgency, gas, and bloating. Align contains Bifantis (Bifidobacterium infantis 35624), a probiotic strain that has been clinically proven to defend against five signs of digestive imbalance. Visit http://www.bifantis.com/ for more information.

Woodward Laboratories announces the launch of its Mycocide Nail Fungus Test Kit, the first at-home screening kit that helps diagnose toenail and fingernail fungus. The new test kit makes diagnosing nail fungus fast and easy, says the company. If use of the kit indicates that there is fungus on the finger and/or toe areas, Woodward Labs offers Mycocide NS Antifungal Treatment. Visit http://www.isitnailfungus.com/ for more information.