Generic Product News

Latanoprost Ophthalmic Solution 0.005%

Marketed by: Mylan Pharmaceuticals, a subsidiary of Mylan Inc (Pittsburgh, PA)

Compared to: Xalatan (Pfizer)

Indication: Mylan’s subsidiary Mylan Pharmaceuticals announced the FDA approval of latanoprost ophthalmic solution, a generic version of Pfizer’s Xalatan. Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The recommended dosage is 1 drop in the affected eye once daily in the evening. Contact lenses should be removed before administering the solution and may be reinserted after 15 minutes. Patients taking the medication should be informed of the possibility of increased pigmentation of the iris, eyelid, and eyelashes that is associated with latanoprost ophthalmic solution. Dosage Form: Drops: 2.5 mL solution of latanoprost 0.005%

For More Information: www.mylan.com

Zeosa

Marketed by: Teva (North Wales, PA)

Compared to: Femcon Fe (Warner Chilcott)

Indication: Teva introduced Zeosa (norethindrone and ethinyl estradiol tablets USP [chewable] and ferrous fumarate tablets USP [chewable]) tablets, an AB-rated generic oral contraceptive that is bioequivalent to Warner Chilcott’s Femcon Fe tablets. Zeosa is indicated for the prevention of pregnancy in women who choose it as a method of contraception. The 28-day regimen consists of 21 light yellow tablets containing norethindrone and ethinyl estradiol and 7 placebo tablets. The spearmint-flavored tablets can be either chewed or swallowed whole.

Dosage Form: Tablets: 0.4 mg norethindrone and 0.035 mg ethinyl estradiol; Tablets: 75 mg ferrous fumarate

For More Information: www.tevausa.com; 888-TEVA USA (888-838-2872)

Valacyclovir Hydrochloride Tablets

Marketed by: Actavis (Morristown, NJ)

Compared to: Valtrex (GlaxoSmithKline)

Indication: Actavis received FDA approval to market valacyclovir hydrochloride tablets, the generic equivalent to GlaxoSmithKline’s Valtrex Caplets. Valacyclovir hydrochloride tablets are a nucleoside analogue DNA polymerase inhibitor indicated to treat and suppress episodes of genital herpes and reduce transmission of the disease. It is also indicated for the treatment of herpes zoster, or shingles, in adult patients, as well as cold sores (herpes labialis) in both adult and pediatric patients. Patients taking valacyclovir hydrochloride tablets should be reminded that it is a suppressive therapy that does not cure herpes infections.

Dosage Form: Tablets: 500 and 1000 mg

For More Information: www.actavis.com

Imiquimod Cream 5%

Marketed by: Sandoz (Princeton, NJ)

Compared to: Aldara (3M Pharmaceuticals)

Indication: Sandoz announced the FDA approval and launch of imiquimod cream 5%, a generic version of 3M Pharmaceuticals’ Aldara. Imiquimod cream 5% is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults and external genital and perianal warts in patients 12 years and older. Local skin reactions are a common side effect, and patients may take rest periods from applying the cream; however, the total treatment period should not extend beyond 16 weeks. Patients should also avoid sunlight exposure and wear sunscreen daily while using imiquimod cream.

Dosage Form: Imiquimod cream 5% is supplied in single-use packets containing 250 mg, equivalent to 12.5 mg of imiquimod

For More Information: www.us.sandoz.com; 609-627- 8500