Generic Product News

Pharmacy TimesApril 2013 Allergy & Asthma
Volume 79
Issue 4

Coverage of newly released generic medications.

Buprenorphine HCl and Naloxone HCl Dihydrate Tablets

Marketed by: Amneal Pharmaceuticals

Compare to: Suboxone sublingual tablets (Reckitt Benckiser Healthcare Limited)

Indication: Amneal Pharmaceuticals, LLC, has received FDA approval for the generic version of Suboxone sublingual tablets for maintenance treatment of opioid drug dependence. Generic buprenorphine hydrochloride and naloxone HCL dihydrate sublingual tablets are now available in 2 mg/0.5 mg and 8 mg/2mg strengths, both in 30-count bottles and with an orange flavor.

Dosage Form: Tablets: 2 mg/0.5 mg, 8 mg/2 mg

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Levofloxacin Injection

Marketed by: AuroMedics Pharma LLC

Compare to: Levaquin (Janssen Pharmaceuticals Inc)

Indication: Aurobindo Pharma Limited has received final approval from the FDA to manufacture and market levofloxacin injection, 25 mg/mL, packaged in 500 mg/20 mL and 750 mg/30 mL single-use vials. It is indicated for the treatment of adults with infections caused by designated, susceptible bacteria, such as pneumonia, acute bacterial sinusitis, and complicated urinary tract infections. It will be marketed and sold by Aurobindo’s US subsidiary, AuroMedics Pharma LLC.

Dosage Form: Single-Use Vials: 500 mg/20 mL, 750 mg/30 mL

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Rizatriptan Benzoate Tablets

Marketed by: Par Pharmaceutical Inc

Compare to: Maxalt/Maxalt-MLT (Merck & Co, Inc)

Indication: Rizatriptan benzoate tablets and rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and children aged 6 to 17 years. Rizatriptan benzoate is contraindicated in patients with ischemic artery disease or other significant underlying cardiovascular disease, coronary artery vasospasm, history of stroke or transient ischemic attack, peripheral vascular disease, ischemic bowel disease, and uncontrolled hypertension.

Dosage Form: Tablets: 5 mg, 10 mg; Orally Disintegrating Tablets: 5 mg, 10 mg

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Acetylcysteine Injection

Marketed by: APP, a division of Fresenius Kabi USA LLC

Compare to: Acetadote (Cumberland Pharmaceuticals Inc)

Indication: Acetylcysteine injection is indicated to prevent or lessen hepatic injury, which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. InnoPharma Inc developed acetylcysteine injection and, as part of its approval, received 180-day generic exclusivity for the drug. Fresenius Kabi has a licensing agreement with InnoPharma to sell, market, and distribute acetylcysteine injection in the United States.

Dosage Form: Single-Use Vial: 30 ml (200 mg/ mL concentration)

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Alfuzosin Hydrochloride Extended-Release Tablets

Marketed By: Wockhardt

Compare to: Uroxatral (Sanofi-Aventis)

Indication: Alfuzosin hydrochloride 10-mg extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. The tablets should be taken once daily with food, with the same meal each day, and should not be chewed or crushed. Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population or for the treatment of hypertension.

Dosage Form: Extended-release tablets: 10 mg

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Argatroban Injection 50mg/ 50mL, Aqueous Solution

Marketed by: Sandoz

Compare to: Argatroban Injection Aqueous Solution (Eagle Pharmaceuticals)

Indication: Sandoz has launched an authorized generic version of Eagle Pharmaceuticals’ ready-to-use argatroban injection 50 mg/50mL aqueous solution. It is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia and as an anticoagulant in adult patients with or at the risk of heparin-induced thrombocytopenia while undergoing percutaneous coronary intervention.

Dosage Form: Single-use vials: 50mg/mL (1mg/mL)

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Hydrocortisone Tablets, USP

Marketed by: Greenstone LLC Compare to: Cortef (Pfizer Inc)

Indication: Greenstone LLC, a US-based generic pharmaceutical subsidiary of Pfizer Inc, announces the introduction of hydrocortisone tablets, USP, to its generic pharmaceutical product line. It is the authorized generic of, and equivalent to, Pfizer’s Cortef, and is indicated for the treatment of certain types of endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, and nervous system diseases, disorders, and states. Dosage Form: Tablets: 5 mg, 10 mg, 20 mg

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Betamethasone Valerate Foam 0.12%

Marketed by: Cobrek Pharmaceuticals, Inc

Compare to: Luxiq Foam (Stiefel Laboratories)

Indication: Perrigo Company announces that its partner, Cobrek Pharmaceuticals, Inc, received approval from the FDA for betamethasone valerate foam 0.12%, the generic equivalent of Luxiq Foam. Cobrek was first to file its Abbreviated New Drug Application, making it eligible for 180 days of marketing exclusivity. Betamethasone valerate foam 0.12% is indicated for the relief of scalp psoriasis.

Dosage Form: Topical Foam: 0.12%

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Zoledronic Acid Injection 4 mg/5 mL

Marketed by: Dr. Reddy’s Laboratories

Compare to: Zometa 4 mg/5 mL (Novartis AG)

Indication: Dr. Reddy’s Laboratories announced that it has launched zoledronic acid injection 4 mg/5mL, a bioequivalent generic version of Zometa 4 mg/5 mL injection in the US market on March 4, 2013, following approval by the United States Food and Drug Administration. The bisphosphonate medication is available in a single-use vial of concentrate.

Dosage Form: Single-use vial: 4 mg/5 mL

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Fluvoxamine Maleate Capsules

Marketed by: Par Pharmaceutical Companies, Inc

Compare to: Luvox CR (Jazz Pharmaceuticals)

Indication: Par Pharmaceutical Companies, Inc, announced the approval of its ANDA for fluvoxamine maleate 100-mg and 150-mg extended-release capsules. It is indicated for the treatment of obsessive-compulsive disorder. As the first company to submit a complete ANDA for the product, Par Pharmaceuticals has been awarded 180 days of marketing exclusivity.

Dosage Form: Capsules: 100 mg, 150 mg

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