PHARMACY

Mucinex with Codeine receives approvable letter from FDA

BY Drew Buono

CHESTER, N.J. The Food and Drug Administration has issued an approvable letter to Adams Respiratory Therapeutics application for Mucinex with Codeine and codeine phosphate extended-release bi-layer tablets.

In addition to some preliminary labeling comments, the FDA has requested additional data to support the use of the product with food. “An approvable letter for Mucinex with Codeine is a positive step in the FDA review process,” said chief operating officer Robert D. Casale.

The company also announced that its fiscal 2008 will be close to $440 million. The new Mucinex with Codeine is not expected to impact this number. The company will release these results on Nov. 8th.

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Amgen cuts fewer jobs in R.I. than predicted

BY Allison Cerra

WEST GREENWICH, R.I. Despite last month?s reports that drug maker Amgen would lay off 450 employees from its Rhode Island staff, the number is proving to be lower, according to the Associated Press.

Instead, according to reports, Amgen cut 300 employees, after realizing that it needed more workers to help manufacture Enbrel, an arthritis drug.

Amgen has roughly 1,600 workers in Rhode Island. It plans to close one of its manufacturing plants by the end of the year.

The company plans to lay off 1,500 employees across the country as part of a major cost-cutting plan.

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Edwards suggests new drug ads wait for two years

BY Allison Cerra

LACONIA, N.H. Presidential hopeful John Edwards said Sunday he had outlined a plan to regulate prescription drug companies and their advertising. Edwards suggested that drug makers wait two years to begin advertising their new products to consumers since the cost of advertising has escalated to nearly $4 billion over the past decade.

The two-year delay would prevent television ads from driving consumers to drugs that haven’t been proven safe, said Edwards, who also would require drug companies to get Food and Drug Administration approval before launching major ad campaigns.

“I think two years makes sense. I think it gives enough time for a drug not just to have been tested in clinical trials but to be out among the public, to see what kind of adverse reactions there have been,’’ he told reporters afterward.

Edwards’ plan also includes augmented penalties for companies that violate truth-in-advertising laws, and would require companies to disclose more information about a drug’s side effects and effectiveness compared to placebos and less expensive alternative drugs.

The Democratic hopeful said this idea would ensure that “salesmanship is not trumping the facts, so people learn what the real risks are associated with these drugs,” Edwards said.

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