Generic Product News

Pharmacy TimesAugust 2014 Pain Awareness
Volume 80
Issue 8

Marketed by: Perrigo Company Plc and Impax Laboratories, Inc

Compare to: Astepro Nasal Spray (Meda Pharmaceuticals, Inc)

Indication: Perrigo Company plc has announced that it has received FDA approval of its Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal solution, 0.15%. The ANDA involved contributions from Perrigo and Impax Laboratories, Inc, which will share certain costs and benefits of this product. It is indicated for the relief of symptoms of seasonal and perennial allergic rhinitis in patients 12 years and older.

Dosage Form: Nasal spray: 0.15%

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Mimvey Lo

Manufactured by: Teva Pharmaceuticals

Compare to: Activella Tablets (Novo Nordisk Femcare)

Indication: Teva Pharmaceuticals has announced the introduction and availability of Mimvey Lo, an AB-rated bioequivalent to Novo Nordisk’s Activella Tablets. The tablets contain estradiol 0.5 mg and norethindrone acetate 0.1 mg. They are indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as the prevention of postmenopausal osteoporosis, in women who have a uterus. When prescribed solely for postmenopausal osteoporosis, therapy should only be considered for women at significant risk, and nonestrogen medications should be considered.

Dosage Form: Tablets: 0.5 mg/0.1 mg

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Valsartan Tablets

Manufactured by: Ohm Laboratories, Inc

Compare to: Diovan (Novartis)

Indication: Ohm Laboratories, Inc, a wholly owned subsidiary of Ranbaxy Laboratories, Limited, announced today that Ohm has received FDA approval to manufacture and market Valsartan 40-, 80-, 160-, and 320-mg tablets on an exclusive basis. Valsartan is the generic version of Novartis’ Diovan. It is indicated for the treatment of high blood pressure and heart failure.

Dosage Form: Tablets: 40, 80, 160, and 320 mg

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Cyclophosphamide Capsules

Manufactured by: Roxane Laboratories

Compare to: Cyclophosphamide tablets (Roxane Laboratories)

Indication: As of June 2014, Roxane Laboratories began providing cyclophosphamide in capsules, an FDAapproved, clinically equivalent version of its discontinued cyclophosphamide tablets. The tablets are indicated for the treatment of malignant lymphomas including Hodgkin’s disease and lymphocytic lymphoma, and minimal change nephrotic syndrome in pediatric patients who fail to respond to adrenocorticosteroid therapy. The new capsules are not automatically substitutable for tablets, so pharmacists should verify that scripts specify capsules in addition to the dosage.

Dosage Form: Capsules: 25 and 50 mg

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Sumatriptan Injection USP, Autoinjector System

Marketed by: Dr. Reddy’s Laboratories

Compare to: Imitrex STATdose Pen (GlaxoSmithKline)

Indication: Dr. Reddy’s Laboratories has announced the launch of its sumatriptan injection USP, autoinjector system, a therapeutic equivalent generic version of GlaxoSmithKline’s IMITREX STATdose Pen (sumatriptan succinate). Sumatriptan injection USP, autoinjector system, is indicated for the acute treatment of migraine with or without aura in adults, and the acute treatment of cluster headaches in adults. It is available in a carton containing 2 single-dose prefilled syringes.

Dosage Form: Autoinjector: 6 mg/0.5 mL

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Potassium Chloride Extended-Release Capsules, USP

Marketed by: Par Pharmaceutical Companies, Inc

Indication: Par Pharmaceutical Companies, Inc, has received FDA approval of its Abbreviated New Drug Application for potassium chloride extended-release (ER) capsules, USP, in 600- and 750-mg strengths. Potassium chloride ER is indicated for the treatment of hypokalemia with or without metabolic alkalosis, digitalis intoxication, and hypokalemic familial periodic paralysis, and for the prevention of hypokalemia in patients who would be at particular risk.

Dosage Form: Capsules: 600 and 750 mg

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Tobramycin Inhalation Solution, USP

Manufactured by: Sandoz

Compare to: TOBI (Novartis Pharmaceuticals Corporation)

Indication: Sandoz has announced the US market introduction of tobramycin inhalation solution, USP, an authorized generic version of TOBI, which is currently marketed by Novartis Pharmaceuticals Corporation. Tobramycin inhalation solution, USP, is indicated for the management of cystic fibrosis patients whose lungs contain Pseudomonas aeruginosa bacteria. Sandoz is marketing tobramycin inhalation solution, USP, in 300-mg/5- mL single-dose ampules, the same size and strength that is currently marketed by the brand manufacturer.

Dosage Form: Single-dose ampules: 300 mg/5 mL

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Xulane Transdermal System

Marketed by: Mylan Pharmaceuticals, Inc

Compare to: ORTHO EVRA (Janssen Pharmaceuticals Inc)

Indication: Mylan Pharmaceuticals, Inc, has launched XULANE (norelgestromin, ethinyl estradiol transdermal system), the generic version of Janssen Pharmaceuticals, Inc’s, ORTHO EVRA. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product. This product is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception.

Dosage Form: Transdermal patch: 150/35 mcg per day

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