Generic Product News

Marketed by: Kremers Urban Pharmaceuticals, Inc

Compare to: Concerta QD (Janssen Pharmaceuticals)

Indication: UCB announced that Kremers Urban Pharmaceuticals, Inc, its US subsidiary focused on specialty generics, received approval for methylphenidate hydrochloride tablets, for which Concerta is listed as the reference product. It is indicated for the treatment of attention deficit hyperactivity disorder in children 6 years and older and adults up to 65 years of age. Each tablet is designed to be effective for 12 hours. Kremers Urban has begun launch operations and supplying the US market with the product.

Dosage Form: Tablets: 18 and 27 mg

For More Information: www.kremersurban.com

Ondansetron Injection, USP

Marketed by: BD Rx Inc

Indication: BD Rx Inc, a subsidiary of medical technology company BD, has introduced Ondansetron Injection, USP, the third drug in its BD Simplist line of ready-to-use prefilled generic injectables. It is used to prevent post operative nausea and vomiting when nasogastric suction is undesirable and can be used with initial and repeat courses of emetogenic cancer chemotherapy. It is also indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.

Dosage Form: Injectable: 4 mg/2 mL

For More Information: www.bd.com

Levofloxacin in Dextrose 5%

Marketed by: Fresenius Kabi USA

Compare to: Levaquin in Dextrose 5% (Janssen Pharmaceuticals)

Indication: Fresenius Kabi USA announces the availability of Levofloxacin in 5% Dextrose injection, a generic equivalent of Janssen Pharmaceuticals’ Levaquin in Dextrose 5%. It is a fluoroquinolone antibacterial indicated for the treatment of bacterial infections caused by susceptible bacteria in pneumonia, bronchitis, skin infections, urinary tract infections, prostatitis, and anthrax infection. Levofloxacin in Dextrose 5% is marketed in Freeflex containers, a multilayer polyolefin film that is non-DEHP and is free of PVC and plasticizer.

Dosage Form: Injectable: 250 mg/50 mL; 500 mg/100 mL; 750 mg/150 mL

For More Information: www.fresenius-kabi.com

Azacitidine for Injection 100 Mg/vial

Marketed by: Dr. Reddy’s Laboratories

Compare to: VIDAZA (Celgene Corporation)

Indication: Dr. Reddy’s Laboratories announced the approval of Azacitidine for Injection 100 mg/vial, a generic bioequivalent version of Celgene Corporation’s VIDAZA, and anticipates a near-term product launch. The product will be available in single-use vials. It is indicated for the treatment of the following French-American-British myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts that are accompanied by ringed sideroblast or thrombocytopenia or requiring transfusions, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.

Dosage Form: Injectable: 100-mg single-use vial

For More Information: www.drreddys.com

Morphine Sulfate Extended-Release Capsules

Marketed by: Upsher-Smith Laboratories, Inc

Compare to: Kadian (Watson Labs, Inc)

Indication: The FDA has approved Upsher-Smith, Inc’s, morphine sulfate tablets, a generic version of Watson Labs’ Kadian. It is AB1 rated and indicated for the treatment of moderate to severe continuous pain. Dosing should account for each patient’s prior experience with analgesics, and patients should be monitored for respiratory depression, particularly within the first 24 to 72 hours of initiating therapy.

Dosage Form: Capsules: 10, 20, 30, 50, 60, 80, and 100 mg

For More Information: www.upsher-smith.com

Metronidazole 1% Topical Gel

Marketed by: Sandoz

Compare to: METROGEL 1% (Galderma Laboratories)

Indication: Sandoz announces the US launch of metronidazole 1% topical gel, the first generic version of METROGEL 1%. It is indicated for the topical treatment of inflammatory rosacea lesions. Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, which should be kept in mind when metronidazole 1% is prescribed to patients receiving anticoagulation therapy despite the low absorption of the topical product.

Dosage Form: Topical gel: 1%

For More Information: www.us.sandoz.com

Fluticasone Proprionate Lotion, 0.05%Marketed by: Perrigo Company

Compare to: Cutivate Lotion, 0.05% (Fougera Pharmaceuticals, Inc)

Indication: Perrigo Company announced that it has received final approval for its abbreviated new drug application for fluticasone proprionate lotion, 0.05%, a generic equivalent of Fougera Pharmaceuticals, Inc’s, Cutivate Lotion, 0.05%. It is indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 1 year or older. Patients should apply a thin film of the product to the affected areas once daily and rub it in gently. Perrigo will commence shipment of the product immediately.

Dosage Form: Topical lotion: 0.05%

For More Information: www.perrigo.com

Benztropine Meylate Tablets

Marketed by: Camber Pharmaceuticals, Inc.

Compare to: Benztropine Mesylate (USL Pharma)

Indication: Camber announces the launch of benztropine mesylate tablets, which is the equivalent of USL Pharma’s benztropine mesylate. It is indicated for use as an adjunct in therapy for all forms of parkinsonism. Therapy should be initiated with a low dose that is increased (in increments of 0.5 mg) at 5- or 6-day intervals to the smallest dose for optimal relief without excessive adverse reactions.

Dosage Form: Tablets: 0.5, 1, and 2 mg

For More Information: www.camberpharma.com

Finasteride 1 mg Tablets

Marketed by: Camber Pharmaceuticals, Inc.

Compare to: Propecia (Merck & Co Inc)

Indication: Camber Pharmaceuticals received final approval from the FDA to market finasteride 1-mg tablets. It is the generic equivalent of Merck’s Propecia and is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in men. Finasteride tablets are not indicated for use in women. Tablets should be taken once daily, with or without a meal.

Dosage Form: Tablets: 1 mg

For More Information: www.camberpharma.com

Fenofibric Acid Delayed-Release Capsules

Marketed by: Mylan Inc

Compare to: TRILIPX (Abbott Laboratories)

Indication: Mylan introduces fenofibric acid delayed-release capsules, a bioequivalent to Abbott Laboratories’ TRILIPIX. It is indicated as an adjunct to diet to reduce triglyceride levels in combination with a statin and increase high-density lipoprotein cholesterol levels in patients with mixed dyslipidemia and coronary heart disease or a coronary heart disease risk equivalent and to reduce triglyceride levels in patients with severe hypertriglyceridemia. For other indications, see the prescribing information.

Dosage Form: Capsules: 45 and 135 mg

For More Information: www.mylan.com

Temozolomide Capsules

Marketed by: Teva Pharmaceutical Industries and Perrigo Company

Compare to: Temodar (Merck, Sharpe, and Dohme Corp)

Indication: Teva Pharmaceutical Industries, Limited, and Perrigo Company announce the launch of temozolomide, the generic equivalent of Temodar. Temozolomide is indicated for the treatment of (1) adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy, and then as maintenance treatment, and (2) refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

Dosage Form: Capsules: 5, 20, 100, 140, 180, and 250 mg

For More Information: www.tevagenerics.com; www.perrigo.com

Lansoprazole Delayed-Release Capsules USP; Amoxicillin Capsules, USP; and Clarithromycin Tablets, USP

Marketed by: Teva Pharmaceuticals

Compare to: Prevpac Kit (Takeda Pharmaceuticals)

Indication: Teva Pharmaceuticals announces the introduction and availability of lansoprazole delayed-release capsules, USP; amoxicillin capsules, USP; and clarithromycin tablets, USP. The product is an AB-rated bioequivalent of Takeda Pharmaceuticals’ Prevpac Kit. It is indicated for the eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence. The recommended dose is 30 mg of lansoprazole, 1 g of amoxicillin, and 500 mg of clarithromycin concurrently twice daily for 10 to 14 days.

Dosage Form: Tablets: 30 mg/500 mg/500 mg

For More Information: www.tevagenerics.com

Adenosine Injection, USP

Marketed by: Teva Pharmaceuticals

Compare to: ADENOSCAN (Astellas Pharma)

Indication: Teva Pharmaceutical Industries Ltd announces the launch of adenosine injection USP, a generic equivalent of Astellas Pharma’s ADENOSCAN. It is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients who are unable to exercise regularly. Adenosine injection USP is available in 20- and 30-mL vials. As the first manufacturer to file, Teva will have 180 days of marketing exclusivity.

Dosage Form: Single-use vial: 20 or 30 mL

For More Information: www.tevagenerics.com

Niacin Extended-Release Tablets, USP

Marketed by: Teva Pharmaceuticals

Compare to: NIASPAN (AbbVie Pharmaceuticals)

Indication: Teva Pharmaceutical Industries Ltd announces the launch of niacin extended-release tablets, a generic equivalent to AbbVie Pharmaceuticals’ NIASPAN. It is indicated, in conjunction with diet, to reduce elevated total cholesterol, low-density lipoprotein cholesterol, and Apo B and triglyceride levels and to increase high-density lipoprotein cholesterol in patients with primary hyperlipidemia and mixed dyslipidemia. It is available in tablet strengths of 500, 750, and 1000 mg.

Dosage Form: Tablets: 500, 750, or 1000 mg

For More Information: www.tevagenerics.com

Doxycycline Hyclate Delayed Release Tablets

Marketed by: Heritage Pharmaceuticals Inc

Compare to: Doryx (Warner Chilcott)

Indication: Heritage Pharmaceuticals Inc announces the immediate availability of doxycycline hyclate delayed release tablets, an AB-rated equivalent to Warner Chilcott’s Doryx. It is indicated for the treatment of severe acne. The recommended dose for adults is 200 mg on the first day of treatment, administered as 100 mg every 12 hours, followed by a maintenance dose of 100 mg daily.

Dosage Form: Tablets: 75, 100, or 150 mg

For More Information: www.heritagepharma.com

Temozolomide Capsules

Marketed by: Sandoz

Compare to: Temodar (Merck)

Indication: Sandoz announces temozolomide capsules, a generic equivalent of Merck’s Temodar. It is indicated for treating newly diagnosed glioblastoma multiforme concomitant with radiotherapy, and as maintenance treatment, and for refractory anaplastic astrocytoma patients. For glioblastoma, the dose is 75 mg/m² for 42 days concomitant with radiotherapy, then an initial maintenance dose of 150 mg/m² once daily for days 1 to 5 of a 28-day cycle of temozolomide. For anaplastic astrocytoma, the initial dose is 150 mg/m² once daily for 5 consecutive days per 28-day treatment cycle.

Dosage Form: Capsules: 5, 20, 100, 140, or 180 mg

For More Information: www.sandoz.us