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Two products from Gavis receive FDA marketing approval.

NEW YORK -- Gavis Pharmaceuticals has introduced GaviLyte-H (a bowel preparation kit) to its product line. This two-liter volume polyethylene glycol (PEG) 3350 with one bisacodyl tablet compares to Half-Lytely (Braintree Laboratories Inc.)

"At Gavis Pharmaceuticals, we remain committed to delivering valuable products to the market that make a difference in people's fives. GaviLyte-H is part of our complete family of generic PEG-3350 products, and is one more example of how GAVIS is listening--and delivering--what patients, physicians and pharmacists want: a choice," says a company statement.

The company also recently introduced methylphenidate HCI chewable tablets, CII (compared to Mallinckrodt LLC's Methylin). Gavis' generic features precise dosing to improve compliance, especially among children who experience difficulty swallowing tablets. It is available in a grape flavor in 2.5, 5 and 10 mgs.

Other generic drag manufacturers have also debuted new products or recently received regulatory approval for them. For example, Aurobindo Pharma Ltd. has been given approval from the Food and Drag Administration for the generic equivalent to Dilantin (extended phenytoin sodium capsules USP, 100 mg). Phenytoin sodium is an antiepileptic product and is indicated for the control of seizures and the prevention and treatment of seizures occurring during or following neurosurgery.

Extended phenytoin sodium capsules USP 100 mg represents the latest addition to Aurobindo's broad fine of pharmaceutical products.

Camber Pharmaceuticals announced that it has launched aripiprazole 2, 5, 10, 15, 20 and 30 mg tablets. The drag is the generic version of Abilify tablets from Otsuka and is used to treat schizophrenia, bipolar disorder and depression. Aripiprazole is available in 30-count bottles.

Glenmark Pharmaceuticals Inc. USA has been granted final approval by the FDA for desmopressin acetate tablets, 0.1 mg and 0.2 mg, the therapeutic equivalent of DDAVP. Other Abbreviated New Drag Applications that have recently been approved for Glenmark are for levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg for calcipotriene cream 0.005%.

Sandoz has announced the U.S. market introduction of guanfacine hydrochloride extended-release tablets, a generic version of Intuniv, which is marketed by Shire Pharmaceuticals. Guanfacine hydrochloride extended-release is a central alpha2A-adrenergic receptor agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. Guanfacine is not a central nervous system (CNS) stimulant. The mechanism of action of guanfacine in ADHD is not known.

"Attention deficit hyperactivity disorder is one of the most common neurodevelopmental disorders of childhood, according to the Centers for Disease Control and Prevention," said Peter Goldschmidt, president of Sandoz.

Teva Pharmaceutical Industries Ltd. announced the launch of the generic equivalent of Lomedia 24 Fe (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 meg and ferrous fumarate tablets, 75 mg) as part of its line of women's health products. The product was launched under the name Junel Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets) and is now available in the United States.

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Title Annotation:RX: RETAIL PHARMACY: Generic Drugs
Publication:Chain Drug Review
Date:Jul 6, 2015
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