Generic Product News

Pharmacy TimesJune 2013 Women's Health
Volume 79
Issue 6

Metoclopramide Injection, USP

Marketed by: BD Rx Inc

Compare to: Reglan (Baxter Health Care Corp)

Indication: The FDA has approved metoclopramide injection, USP, the second product in BD RX Inc’s BD Simplist line of prefilled generic injectables. Metoclopramide injection USP is equivalent to Baxter Health Care Corp’s Reglan, and is indicated for relief of symptoms associated with acute and recurrent diabetic gastric stasis, prevention of vomiting associated with emetogenic cancer chemotherapy, and prevention of postoperative nausea and vomiting where nasogastric suction is undesirable.

Dosage Form: Injection: 10 mg/2 mL prefilled single-use syringe

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Levalbuterol Inhalation Solution, USP

Marketed by: Teva Pharmceuticals

Compare to: Xopenex HFA (Sunovion Pharmaceuticals Inc)

Indication: Teva Pharmaceuticals is pleased to announce the introduction and availability of levalbuterol inhalation solution USP. This product is AN rated and bioequivalent to Sunovion Pharmaceuticals Inc’s Xopenex Inhalation Solution. It is indicated for the treatment and prevention of bronchospasm in adults, adolescents, and children 6 years and older with reversible obstructive airway disease. It is available in 3 strengths, in vial sizes of 3 mL x 24.

Dosage Form: Inhalation Solution: 0.31 mg, 0.63 mg, and 1.25 mg

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Phenoxybenzamine Hydrochloride Capsules, USP

Marketed by: Prasco Laboratories

Compare to: Dibenzyline (WellSpring Pharmaceutical Corp)

Indication: Prasco Laboratories announced today that it has signed an exclusive distribution and supply agreement with WellSpring Pharmaceutical Corp for phenoxybenzamine hydrochloride capsules, USP. As part of the agreement, Prasco, LLC, is prepared to immediately market the authorized generic of Dibenzyline upon the first US, AB-rated entrant. The authorized generic will be marketed in the United States in 10-mg capsules under the Prasco label. The capsules are indicated for the treatment of pheochromocytoma, to control episodes of hypertension and sweating.

Dosage Form: Capsules: 10 mg

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Oxaprozin Caplets

Marketed by: Greenstone LLC

Compare to: DAYPRO (Pfizer Inc)

Indication: Greenstone LLC, a generic pharmaceutical subsidiary of Pfizer Inc, is pleased to announce the introduction of oxaprozin caplets to its generic pharmaceutical product line. It is equivalent to the innovator’s product, DAYPRO. It is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. It is offered in dosage strength of 600 mg. To see the full prescribing information, visit

Dosage Form: Caplets: 600 mg

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Topotecan Injection

Marketed by: Teva Health Systems

Compare to: Topotecan Injection (Hospira, Inc)

Indication: Teva Health Systems announces the availability of topotecan injection, indicated for the treatment of small cell lung cancers in patients with chemotherapy-sensitive disease and in combination therapy with cisplatin for treatment of stage IVB, recurrent, or persistent carcinoma of the cervix.

Dosage Form: Single-dose vial: 1 mg/mL, 4 mL

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Sodium Phenylbutyrate Powder

Marketed by: SigmaPharm Laboratories

Compare to: Buphenyl (Medicis)

Indication: SigmaPharm Laboratories has received FDA approval for sodium phenylbutyrate powder, a generic equivalent of Medicis’ Buphenyl powder. It is indicated as adjunctive therapy in chronic management of patients with Medicis involving deficiencies of carbamylphosphate synthetase, ornithine transarbamylase, or argininosuccinic acid synthetase in patients with neonatal-onset deficiency.

Dosage Form: Powder: 3g/teaspoonful

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Rizatriptan Benzoate Tablets

Marketed by: Teva Pharmaceuticals

Compare to: Maxalt Tablets (Merck, Sharp & Dohme Corp)

Indication: Teva Pharmaceuticals announces the introduction and availability of rizatriptan benzoate tablets. The product is AB rated and equivalent to Merck, Sharp & Dohm Corp’s Maxalt tablets. It is indicated for the treatment of migraine with or without aura in adults and pediatric patients aged 6 to 17 years.

Dosage form: Tablets: 5 mg, 10 mg

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Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets

Marketed by: Aurobindo Pharma Limited

Compare to: Actoplus Met tablets (Takeda Global Research Development Center)

Indication: Aurobindo Pharma Limited received final approvals from the FDA to manufacture and market pioglitazone hydrochloride and metformin hydrochloride tablets. It is the generic equivalent of Takeda Inc’s Actoplus Met tablets and is indicated to improve glycemic control in adults with type 2 diabetes.

Dosage form: Tablets: 15 mg/500 mg, 15 mg/850 mg

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Butalbital, Acetaminophen, and Caffeine Tablets, USP

Marketed by: Lannett Company, Inc

Compare to: Fioricet (Watson Pharma, Inc)

Indication: Lannett Company, Inc, has received FDA approval of its ANDA for butalbital (50 mg), acetaminophen (325 mg), and caffeine (40 mg) tablets, USP. It is indicated for the treatment of tension or muscle contraction headaches. It is contraindicated for patients with hypersensitivity or intolerance to product components as well as in patients with porphyria.

Dosage Form: Tablets: 50 mg/325 mg/40mg

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Alendronate Sodium Oral Solution 70 MG/75 ML

Marketed by: TAGI Pharma, Inc

Compare to: Fosamax (Merck & Co, Inc)

Indication: TAGI Pharma, Inc, a specialty pharmaceutical company and subsidiary of Precision Dose, Inc, has signed an exclusive agreement to market and sell alendronate sodium oral solution 70 mg/75 mL in the United States. It is an FDA-approved generic alternative to Merck & Co, Inc’s, Fosamax, and is indicated for the treatment of osteoporosis in postmenopausal women and as a treatment to increase bone mass in men with osteoporosis.

Dosage Form: Oral solution: 70 mg/75 mL

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