Generic Product News

Sandoz Inc (Princeton, NJ)

Compared to:

Genotropin (Pfizer)

Indication:

Sandoz announced the FDA approval of a new indication for their biologic Omnitrope (somatropin [rDNA origin]). Omnitrope is now indicated for the treatment of children with Idiopathic Short Stature (ISS). ISS, also called non-growth hormone deficient short stature, is a diagnosis used to describe children or adolescents who are extremely short for their age, but show no evidence of a disorder or systemic, endocrine, nutritional, or chromosomal abnormalities.

Dosage Form:

Pen: 10 and 5 mg, vial: 5.8 mg

For More Information:

www.us.sandoz.com; 609-627-8500

Adapalene Gel, 0.1%Marketed by:

Teva Pharmaceuticals (North Wales, PA)

Compared to:

Differin Gel, 0.1% (Galderma Laboratories)

Indication:

Teva Pharmaceuticals announced the launch of Adapalene Gel, the AB-rated generic equivalent to Galderma Laboratories’ Differin Gel. Adapalene Gel is indicated for the topical treatment of acne vulgaris. It should be applied in a thin film to affected areas after washing once daily before bedtime. During the first 2 to 4 weeks of treatment, patients may experience dryness, scaling, burning, or itching, which usually lessen with continued use. An apparent worsening of acne may occur in the early weeks of treatment, but should not be considered a reason to discontinue therapy. Therapeutic results should occur after 8 to 12 weeks.

Dosage Form:

Topical gel: 45-g tube

For More Information:

www.tevausa.com; 888-838-2872

BUPROPION HCI SR TABLETS

Marketed by:

Actavis (Morristown, NJ)

Compared to:

Wellbutrin SR (GlaxoSmithKline)

Indication:

Actavis received FDA approval to market and distribute Bupropion HCl Extended-Release (SR) tablets in strengths of 100 mg and 200 mg. The new strengths complement Actavis’s already approved Bupropion HCl SR 150 mg, which is indicated for the treatment of major depressive disorder. The usual adult target dose for Bupropion is 300 mg per day, taken once daily in the morning; however, dosage strengths are typically increased gradually, beginning with an initial treatment of 150 mg per day, taken once daily in the morning.

Dosage Form:

Tablets: 100-, 150-, and 200-mg strengths

For More Information:

www.actavis.us; 973-993-4500 74

Hydrocodone Polistirex and Chlorpheniramine Polistirex (CIII) Extended-Release (ER) Oral SuspensionMarketed by:

Tris Pharma, Inc (Monmouth Junction, NJ)

Compared to:

Tussionex (UCB Manufacturing Inc)

Indication:

Tris Pharma, Inc, in partnership with Par Pharmaceuticals, announced the final FDA approval of the first generic equivalent to UCB’s Tussionex. Hydrocodone polistirex and chlorpheniramine polistirex (CIII) extended-release (ER) oral suspension is indicated for the relief of cough and upper respiratory symptoms from allergy or cold in adults and children 6 years and older. Each 5-mL dose contains the equivalent of 10 mg of hydrocodone bitartrate and 8 mg of chlorpheniramine maleate, and provides relief for up to 12 hours. Patients should be reminded to use approved measuring devices when administering doses and to avoid operating machinery or driving while taking the medication.

Dosage Form:

Oral suspension

For More Information:

www.trispharma.com; 732-940-2800 PT