Generic Product News

Marketed by:

Teva Pharmaceuticals (North Wales, PA)

Compared to:

Topamax (Ortho-McNeil- Janssen Pharmaceuticals)

Indication:

Teva Pharmaceuticals announced the introduction and availability of Topiramate Tablets. The product is AB-rated and bioequivalent to Topamax Tablets. Topiramate Tablets are indicated as initial monotherapy in patients aged ≥10 years with partialonset or primary generalized tonic-clonic seizures, and as adjunctive therapy for adults and pediatric patients aged 2 to 16 with partial-onset or primary generalized tonic-clonic seizures, and in patients aged ≥2 years with seizures associated with Lennox-Gastaut syndrome.

Dosage Form:

Tablets: 25, 50, 100, and 200 mg

For More Information:

www.tevausa.com; 888-TEVA-USA

Marketed by:

Paddock Laboratories Inc (Minneapolis, MN)

Compared to:

Lorazepam Intensol (Roxane Laboratories)

Indication:

Paddock Laboratories has launched Lorazepam Oral Concentrate USP CIV, an antianxiety agent that is AA-rated to Lorazepam Intensol Oral Concentrate (Roxane Laboratories). The product is available in a 30-mL bottle in 2-mg/mL strength. The product is indicated for the management of anxiety disorders, for the short-term relief of the symptoms of anxiety, or for anxiety associated with depressive symptoms. It is readily absorbed with an absolute bioavailability of 90%.

Dosage Form:

Oral concentrate: 2 mg/mL

For More Information:

www.paddocklabs.com

800-328-5113

Extended Phenytoin Sodium Capsules

Marketed by:

Amneal Pharmaceuticals (Hauppauge, NY)

Compared to:

Dilantin (Parke-Davis)

Extended Phenytoin Sodium Capsules (Mylan Pharmaceuticals Inc)

Indication:

Amneal Pharmaceuticals received FDA confirmation that its Extended Phenytoin Sodium Capsules USP 100 mg are bioequivalent to Mylan Pharmaceuticals Inc’s extended phenytoin sodium capsules, making Amneal’s product an AB-rated, therapeutically equivalent alternative to both the brand and the generic product. Extended Phenytoin Sodium Capsules are indicated for the control of generalized tonic-clonic and complex partial seizures and for prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments.

Dosage Form:

Capsules: 100 mg

For More Information:

www.amneal.com

Mycophenolate Mofetil

Marketed by:

Roxane Laboratories (Columbus, OH)

Compared to:

CellCept (Hoffmann-La Roche Inc)

Indication:

Roxane Laboratories announced the launch of Mycophenolate Mofetil 250-mg capsules and 500-mg tablets. Mycophenolate Mofetil is AB-rated to CellCept, and is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. The product should be used concomitantly with cyclosporine and corticosteroids. Mycophenolate Mofetil has been administered in combination with the following agents in clinical trials: antithymocyte globulin (Atgam), OKT3 (Orthoclone OKT4 3), cyclosporine (Sandimmune, Neoral), and corticosteroids. The efficacy and safety of the use of Mycophenolate Mofetil in combination with other immunosuppressive agents have not been determined.

Dosage Form:

Capsules: 250 mg

Tablets: 500 mg

For More Information: www.roxane.com â–