/publications/issue/2011/November2011/Generic-Products-

Generic Products

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Atorvastatin

Marketed by: Ranbaxy (Jacksonville, FL)

Compared to: Lipitor (Pfizer) Indication: Ranbaxy announced the FDA approval and US launch of atorvastatin, the first generic version of Pfizer’s cholesterol-lowering drug Lipitor. Atorvastatin is indicated to reduce low-density lipoprotein and triglycerides and increase high-density lipoprotein (HDL) in patients whose high cholesterol is not improved by diet and exercise alone. It is also used to lower risk of myocardial infarction, stroke, heart surgery, and angina in patients who have heart disease or who have multiple risk factors for heart disease, such as age, smoking, hypertension, low HDL cholesterol, or a family history of early heart disease.

Dosage Form: Tablets: 10, 20, 40, and 80 mg

For More Information: www.ranbaxy.com; 1-888-RANBAXY

Tranexamic Acid Injection

Marketed by: Mylan (Pittsburgh, PA)

Compared to: Cyklokapron Injection (Pharmacia & Upjohn) Indication: Mylan announced that Mylan Institutional received FDA approval for tranexamic acid injection 100 mg/mL, a generic version of Pharmacia & Upjohn’s Cyklokapron. Tranexamic acid is indicated for short-term use in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during and after oral surgery. The recommended dosage of tranexamic acid is 10 mg per kg of a patient’s body weight, administered immediately before surgery and 3 to 4 times daily during the 2 to 8 days following surgery.

Dosage Form: Intravenous injection: 100 mg/mL

For More Information: www.mylan.com


Amlodipine Besylate/ Atorvastatin Calcium Tablets

Marketed by: Ranbaxy (Jacksonville, FL)

Compared to: Caduet (Pfizer)

Indication: Ranbaxy launched its authorized generic version of Caduet, a fixed-dose combination of the calcium channel blocker amlodipine with the lipid-lowering agent atorvastatin. It is indicated for patients with both hyperlipidemia and either hypertension or angina, for whom treatment with amlodipine and atorvastatin is appropriate. The dosage should be adjusted for each patient based on effectiveness and tolerance of the monotherapies.

Dosage Form: Tablets: 2.5/10, 2.5/20, 2.5/40, 5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, 10/80 mg amlodipine besylate/atorvastatin calcium

For More Information: www.ranbaxy.com; 1-888-RANBAXY

Camrese Lo

Marketed by: Teva Pharmaceuticals (North Wales, PA)

Compared to: LoSeasonique (Teva Women’s Health)

Indication: The FDA approved Camrese Lo (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets), a low-dose extendedregimen oral contraceptive that is equivalent to LoSeasonique. Women taking Camrese Lo can expect to have 4 scheduled periods per year, each lasting 2 to 3 days. Bleeding or spotting between cycles is normal, and tends to decrease with time. The dosage for Camrese Lo is 1 orange tablet containing levonorgestrel and ethinyl estradiol taken daily for 84 consecutive days, followed by 1 yellow ethinyl estradiol tablet for 7 days. It is packaged in extended-cycle tablet dispensers, each containing a 13-week supply of tablets.

Dosage Form: Tablets: 0.1 mg levonorgestrel/0.02 mg ethinyl estradiol; 0.01 mg ethinyl estradiol

For More Information: www.tevausa.com