Chain Drug Review - Generics makers keep product pipeline active
WASHINGTON — American Pharmaceutical Partners Inc. has received Food and Drug Administration approval of its abbreviated new drug application (ANDA) for azithromycin for injection.
The company anticipates that it will market the product, the generic equivalent of Pfizer Inc.’s Zithromax, in the first quarter of this year.
Azithromycin for injection is indicated for treating community-acquired pneumonia and pelvic inflammatory disease.
“The addition of azithromycin expands our anti-infective portfolio to 18 products and extends to 11 the number of different classes of anti-infectives the company offers,” says Patrick Soon-Shiong, chairman and chief executive officer.
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The preservative-free product is being made available in 500-mg vials, each of which will include a bar code and latex-flee vial stopper.
Other companies receiving generic drug product approvals include:
* Apotex Corp. It has been given clearance for zonisamide capsules in 25-, 50- and 100-mg strengths. Available in 100-count bottles, the product is the generic equivalent to Zonegran and is used to treat epilepsy. Barr Pharmaceuticals Inc. and Mylan Laboratories Inc. have also won approval for generic versions of the Eisai Inc. drug.
* Caraco Pharmaceutical Laboratories Ltd. The company will launch tramadol hydrochloride with acetaminophen tablets. The product is the generic equivalent of Ortho-McNeil Pharmaceutical Inc.’s Ultracet brand, indicated for the short-term management of acute pain. Detroit-based Caraco has also been given approval for carbamazepine tablets USP. The product is the generic equivalent of Tegretol, Novartis Pharmaceutical Corp.’s anticonvulsant.
* Ivax Corp. It has received approval of its ANDA for 200-mg doses of clozapine. The product is the generic equivalent to Novartis’ Clozaril, a schizophrenia treatment.
* Par Pharmaceutical Cos. It has been given clearance for cefprozil tablets, the generic version of Bristol-Myers Squibb Co.’s Cefzil. The product is a broad-spectrum cephalosporin antibiotic. The company has also begun shipping doxycycline monohydrate tablets, an authorized generic version of Adoxa, licensed from Bradley Pharmaceuticals Inc.
* Teva Pharmaceuticals USA. The company has debuted oxycodone hydrochloride extended-release tablets, CII, in 10-, 20- and 40-mg strengths. The product is bioequivalent to Oxy-Contin tablets, which are marketed by Purdue Pharma LP. Teva has also rolled out ribavirin tablets. Available in a 200-mg strength, the product is AB-rated to Hoffmann-La Roche Inc.’s Copegus.
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