Manufacturers keep product pipeline moving ahead.
WASHINGTON -- Ranbaxy Pharmaceuticals Inc. says it has become the first company to have been granted generic approval for the oral suspension form and tablet version of clarithromycin.
"We are pleased to receive this FDA [Food and Drug Administration] approval for clarithromycin for oral suspension USP [125 mg/5 mL and 250 mg/5mL], an anti-infective agent that will add depth and breadth to our product line of anti-infectives, which also includes clarithromycin tablets," asserts vice president of sales and distribution Jim Meehan. "We will be in a position to offer both dosage forms for this molecule, which will distinguish Ranbaxy in the marketplace.
"This approval further expands our product portfolio of affordable generic alternatives and will be shipped to all classes of trade."
The drug is the equivalent to Abbott Laboratories' Biaxin and is indicated for treating mild to moderate infections. The Sandoz generics unit of Novartis AG has also launched its version of the macrolide antibiotic in suspension form.
Sandoz has also announced that it has extended its line of generic Augmentin medicines (amoxicillin and clavulanate potassium), used to treat bacterial infections. In addition, the company has launched a generic version of Penlac topical solution (ciclopirox topical solution), a nail lacquer used to treat fungal infections of the fingernails and toenails.
Hi-Tech Pharmacal Co., Perrigo Co., Synerx Pharma LLC, Taro Pharmaceutical Industries Ltd. and Teva Pharmaceuticals also received final abbreviated new drug application approvals for their versions of ciclopirox topical solution.
Teva has also rolled out famciclovir tablets. They are the generic equivalent of Famvir (Novartis AG).
Barr Laboratories Inc. has challenged patents listed by Novartis Pharmaceuticals Corp. in connection with Ritalin LA extendedrelease capsules in 10-, 20-, 30- and 40-mg strengths. Known by its genetic name of methylphenidate hydrochioride, the product is indicated for treating attention deficit/hyperactivity disorder.
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|Title Annotation:||RX RETAIL PHARMACY: Generic Drugs|
|Publication:||Chain Drug Review|
|Date:||Nov 19, 2007|
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