Andrx cleared to market generic version of Tiazac. (RX: Generic Drugs).
WASHINGTON -- Andrx Corp. has received Food and Drug Administration approval for a generic version of Tiazac. The clearance by the regulatory agency ends a five-year legal fight that pitted Florida-based Andrx against Biovail Corp., the brand manufacturer headquartered in Toronto.
Biovail had placed several patents over the product to prevent generic versions from reaching the United States. The product is marketed in the U.S. by Forest Laboratories Inc.
Although Biovail agreed to suspend its challenge approximately a year ago, the FDA still had to determine whether Andrx' version was equivalent to the original product, which had U.S. sales of approximately $270 million.
Ivax has also reiterated it believes it has first-to-file status on 100-, 300and 400-mg dosages of gabapentin tablets. Gabapentin is the active ingredient in Neurontin, an epilepsy drug marketed by the Warner-Lambert unit of Pfizer Inc. The company made the distinction in the aftermath of a federal court ruling upholding the FDA's decision that Alpharma Inc. is the only company entitled to 180-day marketing exclusivity for gabapentin tablets.
Ivax has also announced receiving tentative approval for pergolide mesylate tablets in .05-, .25- and 1-mg strengths. It is the generic equivalent of Permax tablets (Amarin Corp. PLC).
In other marketing-related announcements involving generic drug manufacturers:
* Able Laboratories Inc. received approval for two additional formulations of promethazine HCL suppositories USP. All three strengths are generic equivalents of Wyeth-Ayerst Laboratories' Phenergan.
* Impax Laboratories Inc. has been given clearance for generic Mestinon (pyridostigmine bromide) 60-mg tablets. ICN Pharmaceuticals Inc. markets the brand name product, indicated for myastenia gravis, a neuromuscular disorder. eLannett Co. has been given approval for dextroamphetamine sulfate tablets in 5- and 10-mg potencies. They are the generic equivalents to Shire Pharmaceuticals' Dextrostat and GlaxoSmithKline's Dexedrine, both used to treat attention deficit hyperactivity disorder and narcolepsy.
* Teva Pharmaceuticals Industries Ltd. has been given clearance for hydrocodone bitartrate and ibuprofen tablets. They are AB-rated generic equivalents to Abbott Laboratories' Vicoprofen, indicated for shortterm management of acute pain.
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|Comment:||Andrx cleared to market generic version of Tiazac. (RX: Generic Drugs).|
|Publication:||Chain Drug Review|
|Date:||May 19, 2003|
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