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Generic Rx marketplace expands with flurry of new products.

NEW YORK -- Amneal Pharmaceuticals LLC has launched its ABrated generic for Lutera 28 (levonorgestrel and ethinyl estradiol tablets, USP), 0.1 mg/0.02 mg, the reference listed drug for the former Alesse brand. The Amneal generic will be sold under the trade name Larissia.

Larissia joins four other women's health products (including oral contraceptives and hormone replacement therapies) in the Amneal product line. Several other products are planned for launch before year-end.

"Our women's health product pipeline is rich with complex formulations, new dosage forms and devices dedicated to addressing specific women's health concerns," explains Jim Luce, executive vice president of sales and marketing at Amneal. "We are committed to expanding this category beyond 2016 and continuing to deliver high-quality products and service to this patient population and its health care providers."

Levonorgestrel and ethinyl estradiol tablets, USP 0.1 mg/0.02 mg, were first approved by the Food and Drug Administration in March 1997 under the brand name Alesse.

In recent weeks the FDA has also approved generic drug applications from Aurobindo Pharma Ltd. as well as several other companies. Aurobindo received final regulatory clearance for hydromorphone hydrochloride tablets 2 mg, 4 mg and 8 mg and for zolmitriptan tablets 2.5 mg and 5 mg. The former is used to help relieve moderate to severe acute pain in patients where the use of an opioid is appropriate; the latter is used in the acute treatment of migraine in adults.

Mayne Pharma Inc. received approval from the FDA to market dofetilide capsules, a generic alternative to Tikosyn, an anti-arrhythmic agent used to treat irregular heartbeats, such as atrial fibrillation and atrial flutter.

Mayne Pharma says it was the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for dofetilide capsules. As a result, the FDA awarded Mayne Pharma 180 days of market exclusivity for its generic alternatives. The company immediately began selling the product in 125-mcg (0.125-mg), 250-mcg (0.25-mg) and 500-mcg (0.5-mg) doses.

Company officials note that the timing of Mayne Pharma's market approval coincided with the FDA's withdrawal of the Tikosyn Risk Evaluation and Mitigation Strategies (REMS) program, which limited the drug's availability and dispensation to certified prescribes, pharmacies and wholesalers. The removal of the drug's REMS program means that Mayne Pharma's dofetilide capsules can be broadly available at pharmacies nationwide.

Dofetilide capsules are a generic version of Pfizer Inc.'s Tikosyn capsules.

Several new generics have been rolled out by Mylan Inc. Earlier this month the company launched fenofibrate tablets USP, 40 mg and 120 mg, which is a generic version of Santarus' Fenoglide. Mylan received final approval from the FDA for its ANDA for this product, which is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides and apolipoprotein B to increase high-density lipoprotein in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

Mylan has also launched dutasteride capsules, 0.5 mg, the generic version of GlaxoSmithKline's Avodart capsules. This product is indicated as a monotherapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery. It may also be used with tamsulosin for the treatment of symptomatic BPH in men with an enlarged prostate.

The company has also introduced Azacitidine for Injection, 100 mg/ vial, which is a generic version of Celgene's Vidaza Injection, 100 mg/ vial. Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of the five French-American-British subtypes of myelodysplastic syndrome, a blood cell disorder that can occur as a result of cancer treatments or can progress to leukemia.
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Title Annotation:RX/Generic Drugs
Publication:Chain Drug Review
Date:Jul 25, 2016
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