PHARMACY

Ranbaxy receives FDA approval for generic Vicodin

BY Adam Kraemer

PRINCETON, N.J. The Food and Drug Administration has granted approval to Ranbaxy Laboratories for the manufacture and market of hydrocodone bitartrate and acetaminophen tablets USP, 7.5 mg/750 mg, 10 mg/500 mg, 5 mg/500 mg and 10 mg/325 mg strengths, Ranbaxy Pharmaceuticals announced today.

The FDA’s Office of Generic Drugs determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drugs as follows: Watson Pharmaceuticals’ Norco, Abbott’s Vicodin and Vicodin ES tablets and UCB’s Lortab tablets.

Total annual market sales for hydrocodone bitartrate and acetaminophen tablets were $390.6 million, according to IMS data.

“Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain, and Ranbaxy is pleased to receive final FDA approval for multiple strengths of this product,” stated Jim Meehan, vice president of sales and marketing for Ranbaxy. “These approvals further expand our product portfolio of affordable generic alternatives and will be launched in a November 2007 time period to all classes of trade.”

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Patent office sends Pfizer “non-final” rejection letter for Lipitor

BY Adam Kraemer

NEW YORK The U.S. Patent and Trademark Office has preliminarily rejected Pfizer’s request for the reissue of a patent for its Lipitor (atorvastatin) cholesterol drug that would preserve its U.S. market exclusivity until 2011, the Wall Street Journal reported.

The U.S. Court of Appeals for the Federal Circuit invalidated in 2006 one of two patents at issue in a legal fight with generic competitor Ranbaxy, which moved up Lipitor’s June 2011 patent expiration and maintaining it instead to March 2010.

Ranbaxy had taken its case to the Supreme Court after the Federal U.S. Circuit Court of Appeals denied the company’s request to rehear the decision. The Supreme Court refused a hearing, preserving the March 2010 date.

Pfizer applied to the patent office in January to have the 2011 patent reissued, and to correct a “technical defect” in the original patent. A reissue would extend Pfizer’s market exclusivity through June 2011.

A Pfizer spokesman told the Journal on Thursday that the company was awaiting a letter from the patent office explaining the decision. Because it’s not a final rejection, Pfizer still has an opportunity to persuade the patent office to reissue the patent.

“An initial rejection is not uncommon in reissue application proceedings,” said Pfizer spokesman Bryant Haskins. “Once we receive the decision we’ll review it and respond appropriately to address any issues that were raised by the examiner.”

Lipitor is the best-selling drug in the world, with $12.9 billion in sales last year. However, it has faced pressure not only from ongoing patent challenges worldwide, but also from competition from generic versions of other anti-cholesterol drugs.

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FDA cites Novartis for distributing ‘misleading’ promotional card

BY Adam Kraemer

WASHINGTON A promotional file card Novartis has put out is “misleading” and misbrands the company’s Alzheimer’s disease drug Exelon, “suggest[ing] that Exelon is safer or more effective than has been demonstrated,” according to a warning letter from the FDA’s Division of Drug Marketing, Advertising and Communications.

According to the Aug. 8 warning letter, posted to the FDA’s website Aug. 14, the file card “makes unsubstantiated superiority claims for Exelon, overstates the efficacy of Exelon, includes misleading risk presentations, and recommends or suggests a combination use of Exelon that has not been approved by FDA.”

Exelon (rivastigmine tartrate) is approved to treat mild-to-moderate Alzheimer’s disease, but is “associated with numerous risks,” such as gastrointestinal adverse reactions including nausea, vomiting and weight loss; anorexia, dyspepsia, asthenia, peptic ulcers and gastrointestinal bleeding; as well as effects on the cardiovascular, pulmonary and neurological systems (i.e., seizures), and risk of urinary obstruction, the warning letter said. The package insert also contains precautions for interactions with other drugs, and warns of potential problems if a patient is given anesthesia.

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