Product Showcase

Generic Supplements, Generic Supplement 2010, Volume 0,0

Marketed by:

Actavis (Morristown, NJ)

Compared to:

Niravam (Azur Pharma Inc)

Indication:

Actavis announced that it received FDA approval to market alprazolam orally distintegrating tablets. The generic equivalent to Niravam, alprazolam orally distintegrating tablets are indicated for the management of anxiety disorder or the short-term relief of symptoms of anxiety. Currently Actavis also offers extended- and immediate-release formulations of alprazolam. Alprazolam orally distintegrating tablets are available in 100-count bottles of 0.25-, 0.5-, 1-, and 2-mg tablets.

Dosage Form:

Tablets: 0.25, 0.5, 1, and 2 mg

For More Information:

www.actavis.us; 973-993-4500

Anastrozole Tablets, 1 mg

Marketed by:

Dr. Reddy’s Laboratories (Charlotte, NC)

Compared to:

Arimidex (AstraZeneca)

Indication:

Following the patent expiration of AstraZeneca’s Arimidex, a nonsteroidal aromatase inhibitor, Dr. Reddy’s announced the launch of anastrozole tablets. Dr. Reddy’s product is the bioequivalent generic version of Arimidex. It is indicated for the treatment of early breast cancer in postmenopausal women; a first-line treatment of locally advanced or metastatic breast cancer; and as a second-line treatment of advanced breast cancer that has progressed following a course of tamoxifen therapy. Nonsteroidal aromatase inhibitors slow or halt the growth of breast cancer cells by decreasing the amount of estrogen produced in the body. Anastrozole is available in 30-count bottles of 1-mg tablets.

Dosage Form:

Tablets: 1 mg

For More Information:

www.drreddys.com; 609-627-8500

Imiquimod Cream 5%

Marketed by:

E. Fougera & Co (Melville, NY), a division of Nycomed US Inc

Compared to:

Aldara (Graceway Pharmaceuticals)

Indication:

E. Fougera & Co announced that it received first generic approval from the FDA for Imiquimod Cream 5%. Imiquimod Cream 5% is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults; biopsy-confirmed, primary superficial basal cell carcinoma in immunocompetent adults—maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured; and external genital and perianal warts/condyloma acuminata in patients 12 years of age or older.

Dosage Form:

Imiquimod Cream 5% is supplied in a box containing 24 single-use packets, each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod

For More Information:

www.fougera.com; 800-645-9833

Oral Transmucosal Fentanyl CitrateMarketed by: Covidien (St. Louis, MO)

Compared to: Actiq (Cephalon Inc)

Indication: Covidien announced that its subsidiary, Mallinckrodt Inc, received FDA approval of its abbreviated new drug application for oral transmucosal fentanyl citrate (CII). Covidien’s product is a generic alternative to Actiq. It is a solid formulation of fentanyl that resembles a lozenge on a handle. Oral transmucosal fentanyl citrate, a class II controlled substance, is an opioid analgesic indicated only for the management of breakthrough cancer pain in patients 16 years of age and older with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying, consistent cancer pain.

Dosage Form: Solid drug matrix on a handle in 200, 400, 600, 800, 1200, and 1600 mcg

For More Information: www.covidien.com

Methocarbamol Tablets USPMarketed by:

Camber Pharmaceuticals Inc (Piscataway, NJ) Compared to: Robaxin (UBC Inc)

Indication:

Methocarbamol tablets USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants. Methocarbamol tablets USP are available in 500 and 700 mg in 100-count and 500-count bottles. For the 500-mg strength, the initial adult dosage is 3 tablets 4 times daily, with a maintenance dosage of 2 tablets 4 times daily. For the 750-mg strength, the initial adult dosage is 2 tablets 4 times daily with a maintenance dosage of 1 tablet every 4 hours or 2 tablets 3 times daily.

Dosage Form:

Tablets: 500 and 750 mg

For More Information:

www.camberpharma.com

E. Fougera & Co (Melville, NY), a division of Nycomed US Inc

Compared to:

Differin (Galderma Laboratories)

Indication:

Fouerga announced the FDA approval of adapalene cream 0.1%, the AB-rated generic equivalent to Galderma Laboratories’ Differin. Adapalene cream is indicated for the topical treatment of acne vulgaris. Adapalene cream should be applied to affected areas of the skin once daily at nighttime. A thin film of the cream should be applied to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Overall clinical benefit may be noticed after 2 weeks of therapy, but at least 8 weeks are required to obtain consistent beneficial effects.

Dosage Form:

Adapalene cream 0.1% is supplied in a 45-g tube

For More Information:

www.fougera.com

Metaxalone Tablets

Marketed by:

Sandoz Inc (Princeton, NJ)

Compared to:

Skelaxin (King Pharmaceuticals Inc)

Indication:

Sandoz Inc announced the launch in the United States of the first generic version of metaxalone tablets, a generic equivalent of King Pharmaceuticals Inc’s Skelaxin. As the first generic version brought to market, Sandoz will have a 180-day abbreviated new drug application exclusivity. Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions.

Dosage:

Tablets: 800 mg

For More Information:

www.us.sandoz.com

Clobetasol Propionate Topical Solution USP 0.05% w/w

Marketed by:

Hi-Tech Pharmacal Co Inc (Amityville, NY)

Compared to:

Temovate Scalp Application 0.05% (PharmaDerm, a division of Nycomed US Inc)

Indication:

Clobetasol propionate topical solution USP 0.05% is indicated for short term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Clobetasol propionate topical solution should be applied to the affected scalp areas twice daily, once in the morning and once at night. Because Clobetasol propionate topical solution is a highly potent corticosteroid, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used. The product is supplied in plastic squeeze bottles of 25 and 50 mL.

Clobetasol propionate is also available in gel, cream, and ointment formulations.

Dosage Form:

Clobetasol propionate topical solution USP 0.05%: 25 and 50 mL

For More Information:

www.hitechpharm.com

Tamsulosin Hydrochloride Capsules USPMarketed by:

Zydus

Compared to:

Flomax (Boehringer Ingelheim Pharmaceuticals)

Indication:

Tamsulosin hydrochloride capsules USP are an alpha1-adrenoceptor antagonist indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. The dosage is 0.4 mg once daily taken approximately one half hour following the same meal each day. This dose can be increased to 0.8 mg once daily for patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing. If discontinued or interrupted for several days, therapy should start again with the 0.4-mg once-daily dose.

Dosage Form:

Capsules: 0.4 mg

For More Information:

www.zydususa.com

Glycopyrrolate Tablets USP, 1 mg and 2 mgMarketed by:

Ranbaxy Pharmaceuticals Inc (Jacksonville, FL), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL)

Compared to:

Robinul 1 mg and Robinul Forte Tablets, 2 mg, respectively (Sciele Pharma Inc)

Indication:

Ranbaxy Pharmaceuticals Inc announced that RLL has received approval from the FDA to manufacture and market Glycopyrrolate Tablets USP, 1 mg and 2 mg. The Ranbaxy formulations are bioequivalent and have the same therapeutic effect as that of the reference-listed drug Robinul 1 mg and Robinul Forte Tablets 2 mg, respectively. Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.

Dosage Form:

Tablets: 1 and 2 mg

For More Information:

www.ranbaxyusa.com

Valacyclovir Hydrochloride Tablets

Marketed by:

Teva Pharmaceuticals (North Wales, PA)

Compared to:

Valtrex (GlaxoSmithKline LLC)

Indication:

Teva Pharmaceuticals announced the availability of valacyclovir hydrochloride tablets. This product is AB-rated and bioequivalent to Valtrex Caplets. Valacyclovir hydrochloride tablets are a nucleoside analogue DNA polymerase inhibitor indicated for cold sores (herpes labialis), genital herpes, and herpes zoster in adult patients, as well as cold sores (herpes labialis) in pediatric patients. The tablets are available in 500- and 1000-mg strengths, in bottle sizes of 30 and 90.

Dosage Form:

Tablets: 500 and 1000 mg

For More Information:

www.tevausa.com; 888-TEVA USA (888-838-2872)

Losartan Potassium and Losartan Potassium-hydrochlorothiazide Tablets

Marketed by:

Sandoz Inc (Princeton, NJ)

Compared to:

Cozaar and Hyzaar (Merck & Co Inc)

Indication:

Sandoz Inc announced the US introduction of losartan potassium and losartan potassium-hydrochlorothiazide (HCTZ) tablets, authorized generic equivalents of Merck’s Cozaar and Hyzaar. Losartan potassium and losartan potassium- HCTZ tablets are intended for the treatment of hypertension. Losartan potassium tablets may be used alone or in combination with other antihypertensive agents, including diuretics. Losartan potassium-HCTZ tablets also are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to black patients.

Dosage Form:

Losartan potassium tablets: 25, 50, and 100 mg Losartan potassium-HCTZ tablets: 50-mg/12.5-mg, 100-mg/12.5-mg, and 100-mg/25-mg strengths

For More Information:

www.us.sandoz.com