New Rx, OTC, and generics (February 2010)

February 15, 2010

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

Key Points

New drugs

Tris Pharma announced that the U.S. Food and Drug Administration (FDA) has approved Clonidine ER suspension and Clonidine ER tablets, which allow for once-daily dosing. Clonidine is a direct-acting alpha 2 adrenergic agonist indicated for the treatment of hypertension. Clonidine ER suspension and Clonidine ER tablets provide the option of 24-hour dosing and use in patients who have difficulty swallowing, in addition to allowing healthcare providers the ability to customize the dose through titration. Clonidine ER suspension are available in a 0.09 mg/mL strength formulation. Clonidine ER tablets are available in 0.17 mg and 0.26 mg dosage strengths. For more information, call 732-940-2800 or visit http://www.trispharma.com/.

Alaven announced the availability of PrimaBella, a noninvasive prescription therapeutic device approved by the FDA for the treatment of nausea and vomiting due to pregnancy (NVP). Worn on the wrist, PrimaBella is a Class II neuromodulation device that emits gentle pulses through the median nerve on the underside of the wrist, which travel to the nausea center in the brain. Visit http://www.PrimaBellaRx.com/ or call 866-943-9426 for more information.

New generics

Sandoz announced the introduction of calcipotriene solution 0.005%, a generic equivalent of Dovonex Scalp Solution 0.005%, in the United States. A synthetic vitamin D3 derivative, calcipotriene is used as a topical solution to treat moderately severe chronic psoriasis of the scalp. Call 609-627-8500 or visit http://www.us.sandoz.com/ for more information.

Mutual Pharmaceutical of Philadelphia has received FDA approval for generic donepezil hydrochloride orally disintegrating tablets in 5 mg and 10 mg strengths. This is the first generic version of Aricept, which is indicated for the treatment of dementia related to Alzheimer's disease. These new tablets dissolve on the tongue and do not have to be swallowed whole. For more information, call 215-288-6500 or visit http://www.urlmutual.com/.

Amneal announced that it has received FDA approval to manufacture Nizatidine Oral Solution in the 15 mg/mL strength. It is a therapeutically equivalent alternative to Axid Oral Solution (a licensed trademark of Braintree Laboratories). The first available generic in oral solution form, Nizatidine Oral Solution is an anti-acid indicated in the treatment and prevention of ulcers, the treatment of heartburn and gastroesophageal reflux disease (the stomach disorder GERD), and the treatment of conditions associated with excess acid secretion. For more information, visit http://www.amneal.com/.

Lannett announced that it has received FDA approval of its ANDAs for hydromorphone hydrochloride tablets USP, 2 mg, 4 mg, and 8 mg, the generic equivalent of Purdue Pharmaceuticals' (formerly Abbott's) Dilaudid tablets 2 mg, 4 mg and 8 mg. Hydromorphone HCl tablets are indicated for the management of pain in patients where an opioid analgesic is appropriate. For more information, call 800-325-9994 or 215-333-9000.

New indications

Lilly announced that the FDA has approved Cymbalta (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults. Cymbalta is a serotonin and norepinephrine reuptake inhibitor already indicated for the initial treatment of GAD, major depressive disorder, and fibromyalgia. For more information, visit http://www.cymbalta.com/or call 800-LILLY-RX.

AstraZeneca announced that Seroquel XR (quetiapine fumarate) extended-release tablets have been approved by the FDA as adjunctive treatment to antidepressants in adults with major depressive disorder (MDD). Seroquel XR is already indicated in adults as monotherapy for acute manic or mixed episodes in bipolar I disorder; as an adjunct to lithium or valproate for acute manic or mixed episodes and maintenance treatment; for depressive episodes associated with bipolar disorder; and for schizophrenia. For more information, call 800-236-9933 or visit http://www.seroquelxr.com/.

New OTC

Merck has announced that the FDA has approved Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) for over-the-counter treatment of frequent heartburn. Zegerid OTC is a proton-pump inhibitor (PPI), the strongest and most effective class of acid-reducing medications available for frequent heartburn. Zegerid OTC treats frequent heartburn by controlling and suppressing acid for a full 24 hours. Visit http://www.ZegeridOTC.com/ for more information.

Gaia Herbs announces Quick Defense Liquid Phyto-Caps, a combination of high-potency organic Echinacea, organic elderberry, organic ginger, and andrographis that helps support the body's immune system at onset of symptoms. Working synergistically, the blend of herbs is quick-acting and needs to be used only for short periods of time during sinus and respiratory challenge. Call 800-831-7780 or visit http://www.gaiaherbs.com/to learn more.

PEDiNOL Pharmacal announced that it has launched Lactinol HX, a new formulation of Lactinol-brand moisturizers. Lactinol HX contains lactic acid to increase the water content of the skin, debride dead skin cells, and promote complete skin health. Lactinol HX is available over the counter. For more information, call 800-733-4665 or visit http://www.pedinol.com/.