Generic Product News (April 2015)

Pharmacy Times, April 2015 Respiratory Health, Volume 81, Issue 4

Read about the new generic products featured in April.

Camber Pharmaceuticals

Compare to: Revatio (Pfizer)

Indication: Camber Pharmaceuticals announces the launch of its sildenafil 20-mg tablets. The product is the generic version of Pfizer’s Revatio tablets and is indicated for the treatment of pulmonary hypertension. Patients should take one 20-mg tablet 3 times per day, 4 to 6 hours apart. Sildenafil tablets are contraindicated in patients taking organic nitrates and in patients with a history of hypersensitivity to sildenafil or any tablet component. The product is available in a 90-count bottle.

Dosage Form: Tablets: 20 mg

For More Information: www.camberpharma.com

Lamivudine TabletsMarketed by: Mylan, Inc

Compare to: Epivir-HBV (GlaxoSmithKline)

Indication: Mylan, Inc, announces the US launch of its lamivudine 100- mg tablets, the generic version of GlaxoSmithKline’s Epivir-HBV. Mylan recently received final approval from the FDA for this product, which is indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation. Use of lamivudine has been associated with lactic acidosis and fatty liver disease. Acute exacerbations of HBV infection have occurred upon discontinuation. In patients with unrecognized or untreated HIV, resistance may emerge while treating HBV infection with lamivudine.

Dosage Form: Tablets: 100 mg

For More Information: www.mylan.com

Enoxaparin Sodium Injection, USPMarketed by: Teva Pharmaceutical Industries Ltd

Compare to: Lovenox (Sanofi)

Indication: Teva Pharmaceutical Industries Ltd announces the launch of its enoxaparin sodium injection, a generic equivalent of Lovenox. Enoxaparin sodium injection, USP, is used for prophylaxis of deep vein thrombosis (DVT) in patients undergoing abdominal surgery or hip or knee replacement surgery, or medical patients with severely restricted mobility during acute illness; it is also used for the treatment of acute DVT. Under a licensing agreement, Teva has partnered with Chemi SPA to leverage its internal research-based technology in the development and manufacture of enoxaparin sodium injection, USP.

Dosage Form: Injectable: 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL, 120 mg/0.8 mL, and 150 mg/1 mL

For More Information: www.tevagenerics.com

Telmisartan TabletsMarketed by: Sandoz

Compare to: Micardis (Boehringer- Ingelheim)

Indication: Sandoz announces the US market introduction of telmisartan tablets, a generic version of Micardis. Telmisartan tablets are an angiotensin 2—receptor blocker indicated for the treatment of hypertension. Sandoz will market telmisartan in 20-, 40-, and 80-mg strength tablets, which are the same strengths as the brand product. The product carries a warning for fetal toxicity; the complete boxed warning is available in the full prescribing information.

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

For More Information: www.sandoz.us

Linezolid InjectionMarketed by: Teva Pharmaceutical Industries, Ltd

Compare to: Zyvox (Pfizer)

Indication: Teva Pharmaceutical Industries, Ltd, has launched linezolid injection, which is the generic equivalent to Pfizer’s Zyvox. It is indicated for the treatment of the following infections caused by gram-positive bacteria: nosocomial pneumonia; community-acquired pneumonia; complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis; uncomplicated skin and skin structure infections; and vancomycin-resistant Enterococcus faecium infection. It is not indicated for the treatment of gram-negative infections. Gram-negative therapy should be initiated immediately if a concomitant gram-negative pathogen is documented or suspended.

Dosage Form: Injection: 600 mg

For More Information: www.tevagenerics.com

Nafcillin for Injection, USPMarketed by: Teva Pharmaceutical Industries, Ltd

Compare to: Nafcillin for Injection, USP (Sandoz)

Indication: Teva Pharmaceutical Industries, Ltd, has launched nafcillin for injection, USP. It is indicated for the treatment of infections caused by penicillinase-producing staphylococci that have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. It is available for intramuscular or intravenous use.

Dosage Form: Injectable: 1 and 2 g/ vial

For More Information: www.tevagenerics.com

Buprenorphine Hydrochloride Sublingual TabletsMarketed by: Mylan, Inc

Compare to: Subutex Sublingual Tablets (Reckitt Benckiser)

Indication: Mylan NV and Mylan, Inc, announce the US launch of buprenorphine hydrochloride sublingual tablets, which is the generic version of Reckitt Benckiser’s Subutex Sublingual Tablets. Mylan received final approval from the FDA for its abbreviated new drug application for this product. It is indicated for the treatment of opioid dependence and is preferred for induction. The product is available in 2- and 8-mg strengths.

Dosage Form: Tablets: 2 and 8 mg

For More Information: www.mylan.com

Disulfiram Tablets, USPMarketed by: Mylan, Inc

Compare to: Antabuse (Odyssey Pharmaceutical)

Indication: Mylan NV and Mylan, Inc, announce the launch of disulfiram tablets, USP, which is the generic version of Odyssey Pharmaceutical’s Antabuse. Mylan received final approval from the FDA for its abbreviated new drug application for this product. It is indicated as an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to the best advantage. The product is available in 250- and 500-mg strengths.

Dosage Form: Tablets: 250 and 500 mg

For More Information: www.mylan.com