Generic Product News (December 2014)

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION (PEDIATRIC)

Marketed by: Amneal Pharmaceuticals

Compare to: Cleocin Pediatric (Pharmacia and Upjohn)

Indication: Amneal Pharmaceuticals announced the launch of clindamycin palmitate hydrochloride for oral solution USP (pediatric), which is available in 75 mg/5 mL reconstituted strength. The Amneal product is an AA-rated therapeutic equivalent to Pharmacia and Upjohn’s Cleocin Pediatric. Mixing the powder with water provides 100 mL of a clear, cherry-flavored solution. It is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria.

Dosage Form: Oral solution: 75 mL/5 mg

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP 1 MG/0.02 MG AND FERROUS FUMARATE Marketed by: Mylan, Inc

Compare to: Loestrin 24 Fe (Warner Chilcott)

Indication: Mylan, Inc, announced the US launch of its norethindrone acetate and ethinyl estradiol tablets, USP, 1 mg/0.02 mg, and ferrous fumarate, which is the generic version of Warner Chilcott’s Loestrin 24 Fe. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Dosage Form: Tablets: 1 mg/0.02 mg

DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, CII Marketed by: Teva Pharmaceuticals

Compare to: Focalin XR Extended- Release Capsules (Novartis AG Corp)

Indication: Teva Pharmaceuticals announced the introduction and availability of dexmethylphenidate hydrochloride extended-released capsules, CII, in a 5-mg strength. The product is AB rated and is bioequivalent to Focalin XR Extended-Release Capsules, CII. With the addition of this new strength, Teva now offers Dexmethylphenidate HCL ER Capsules in 5-mg, 15-mg, 30-mg, and 40-mg strengths.

Dosage Form: Capsules: 5 mg

CYCLOPHOSPHAMIDE INJECTION, USP Marketed by: Sandoz, Inc, and Jiangsu Hengrui Medicine Co

Compare to: Cytoxan (Baxter Healthcare)

Indication: Sandoz announced the US market introduction of cyclophosphamide injection, USP. Sandoz is launching cyclophosphamide injection, USP, through collaboration with Jiangsu Hengrui Medicine Co, the owner of the product’s Abbreviated New Drug Application. Cyclophosphamide for injection, USP, is a chemotherapy agent used to treat certain types of cancer in adults and pediatric patients. It is also used in selected cases of biopsy-proven “minimal change” nephrotic syndrome in children.

Dosage Form: Injection: 500 mg/vial, 1 g/vial, 2 g/vial

For More Information: www.sandoz.com