Generic Product News

Pharmacy TimesFebruary 2014 Autoimmune Disorders
Volume 80
Issue 2

Our round-up of the latest generic products.

Marketed by: Perrigo Company

Compare to: Vanos Cream 0.1% (Medicis, a division of Valeant Pharmaceuticals)

Indication: Perrigo Company has received final approval for fluocinonide cream USP, 0.1%, a generic version of Vanos Cream 0.1%, and has commenced shipment of the product. Fluocinonide cream 0.1% is a corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years or older. Perrigo has been awarded 180 days of generic drug exclusivity as the first company to submit an ANDA containing a paragraph IV certification.

Dosage Form: Cream: 0.1%

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Duloxetine Delayed-Release Capsules, USP

Marketed by: Teva Pharmaceuticals

Compare to: Cymbalta Delayed-Release Capsules (Eli Lilly and Company)

Indication: Teva Pharmaceuticals announces the introduction and availability of duloxetine delayed-release capsules, USP, an AB-rated bioequivalent to Cymbalta Delayed-Release Capsules. It is indicated for the treatment of major depressive disorder, generalized anxiety disorder, and diabetic peripheral neuropathic pain. Capsules should be administered once per day without regard to meals and should be swallowed whole. Capsules should not be chewed, crushed, or opened and sprinkled on foods or mixed with liquids.

Dosage Form: Capsules: 20, 30, and 60 mg

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Diclofenac 3% Gel

Marketed by: Sandoz

Compare to: Solaraze Gel (PharmaDerm)

Indication: Sandoz announces the US launch of diclofenac 3% gel, an authorized generic version of PharmaDerm’s Solaraze Gel. Diclofenac 3% gel is indicated for the topical treatment of actinic keratosis, a precancerous condition of thick, scaly, or crusty patches of skin. Sandoz is marketing diclofenac gel in the 3% strength, which is the only strength marketed as the originator product. It should be applied to lesion areas twice daily, adequately covering the lesion site. Sun avoidance is indicated during therapy.

Dosage Form: Gel: 3%

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Esomeprazole Strontium Delayed-Release Capsules

Marketed by: Amneal Pharmaceuticals

Compare to: Esomeprazole strontium delayed-release capsules (Amneal Pharmaceuticals)

Indication: Amneal Pharmaceuticals announced the launch of generic Esomeprazole strontium delayed-release capsules 49.3 mg. It is the generic equivalent of the recently launched brand Esomeprazole strontium. It contains the same active moiety (esomeprazole) in a different salt form as found in the leading PPI brand Nexium. It is indicated for the treatment of gastroesophageal reflux disease, risk of nonsteroidal anti-inflammatory drug—associated gastric ulcer, Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Dosage Form: Capsules: 49.3 mg

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Digoxin Tablets

Marketed by: Par Pharmaceutical Companies, Inc

Compare to: Lanoxin Tablets (Covis Pharmaceuticals)

Indication: Par Pharmaceuticals Companies, Inc, announced that it has entered into an exclusive supply and distribution agreement with Covis Pharma to distribute the authorized generic version of Covis’ Lanoxin Tablets. Digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults, increasing myocardial contractility in pediatric patients with heart failure, and control of resting ventricular rate in adults with chronic atrial fibrillation. Par has begun shipping 0.125- and 0.25-mg strengths of digoxin tablets.

Dosage Form: Tablets: 0.125 and 0.25 mg

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Telmisartan Tablets, USP

Marketed by: Roxane Laboratories, Inc

Compare to: MICARDIS (Boehringer Ingelheim)

Indication: Roxane Laboratories, Inc, announced the launch of Telmisartan Tablets USP, the authorized generic of Boehringer Ingelheim’s MICARDIS tablets. Telmisartan Tablets are indicated for the treatment of hypertension and to reduce cardiovascular risk in patients unable to take angiotensin-converting enzyme inhibitors. The product is available in unit dose packages of 30 tablets for immediate shipment to wholesalers and pharmacies nationwide.

Dosage Form: Tablets: 20, 40, and 80 mg

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Bromfenac Ophthalmic Solution, 0.09%

Marketed by: Hi-Tech Pharmacal Co, Inc

Compare to: Bromday ophthalmic solution, 0.09% (ISTA Pharmaceuticals)

Indication: Hi-Tech Pharmacal Co, Inc, has received final FDA approval on its Abbreviated New Drug Application for bromfenac ophthalmic solution, 0.09%. Bromfenac ophthalmic solution is the generic for ISTA Pharmaceuticals’ Bromday ophthalmic solution, 0.09%. It is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. The company plans to launch the product immediately.

Dosage Form: Ophthalmic solution: 0.09%

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Toleterodine Tartrate Extended-Release Capsules

Marketed by: Teva Pharmaceutical Industries

Compare to: Detrol LA (Pfizer)

Indication: Teva Pharmaceutical Industries Ltd announced the launch of tolterodine tartrate extended-release capsules, the authorized generic of Detrol LA. Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. It is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. It is also contraindicated in patients with known hypersensitivity to the drug or its ingredients or to fesoterodine fumarate.

Dosage Form: Capsules: 2 and 4 mg

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Repaglinide Tablets

Marketed by: Perrigo Company, PLC

Compare to: Prandin Tablets (Novo Nordisk, Inc)

Indication: Perrigo Company PLC has received final approval from the FDA for its abbreviated new drug application for repaglinide tablets 1 and 2 mg, the generic equivalent to Novo Nordisk’s Prandin Tablets. Perrigo has commenced shipment of the product, after previously launching the 0.5-mg strength of the product in 2013. Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage Form: Tablets: 1 and 2 mg

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