Generic Product News (September 2014)

Zydus Pharmaceuticals (USA) Inc

Compare to: Urocit-K (Mission Pharmacal)

Indication: Zydus Pharmaceuticals (USA) Inc has begun shipping potassium citrate extended-release tablets, a generic equivalent to Mission Pharmacal’s Urocit-K. A generic version of 3 strengths of the product will be available through Zydus. The product is a citrate salt of potassium indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones.

Dosage Form: Extended-release tablets: 5, 10, and 15 mEq

For More Information: www.zydususa.com

Mylan, Inc

Compare to: Micardis Tablets (Boehringer Ingelheim)

Indication: Mylan, Inc, has launched telmisartan tablets USP, 20 mg, 40 mg, and 80 mg, the generic version of Boehringer Ingelheim’s Micardis tablets. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of hypertension, to lower blood pressure. Tablets may be administered with or without food, at a starting dose of 40 mg once daily.

Dosage Form: Tablets: 20, 40, and 80 mg

For More Information: www.mylan.com

Winthrop US, a business of Sanofi US

Compare to: Eloxatin (Sanofi US)

Indication: Sanofi US announced that it has launched an authorized generic version of Eloxatin (oxaliplatin injection) through Winthrop US, the company’s generics division. Sanofi’s authorized generic version is the same formulation as the original drug, for which the company holds the original patent. Oxaliplatin injection is a platinum-based drug used in combination with infusional 5-fluorouracil/leucovorin for the treatment of advanced colorectal cancer or as adjuvant treatment of stage 3 colon cancer in patients who have undergone complete resection of the primary tumor.

Dosage Form: Single-use vials: 50 and 100 mg

For More Information: www.winthropus.com

Dexmethylphenidate Hydrochloride Extended-Release Capsules, CIIManufactured by: Teva Pharmaceuticals

Compare to: Focalin XR (Novartis AG Corp)

Indication: Teva Pharmaceuticals is pleased to announce the introduction and availability of dexmethylphenidate hydrochloride extended-release capsules, CII, in 15- and 30-mg strengths. This product is AB-rated and bioequivalent to Focalin XR Extended-Release Capsules, CII. With the addition of these 2 new strengths, Teva now offers dexmethylphenidate extended-release capsules, CII in 15, 30, and 40 mg.

Dosage Form: Capsules: 15, 30, and 40 mg

For More Information: www.tevagenerics.com