Archive for July 13th, 2010

FDA warns maker of asthma drug Zyflo CR of legal violations in marketing materials

The U.S. Food and Drug Administration (FDA) has issued a warning letter to the maker of an asthma drug for marketing materials that inflated the drug’s benefits while not reporting some of its risks.

The June 22 letter to drug maker Cornerstone Therapeutics Inc. stated that the company’s web page about Zyflo CR failed to provide information about the drug’s risks, such as liver toxicity, sleep disorders, and behavioral changes, or that the drug is not recommended for patients with liver disease or a history of allergic reactions to the ingredients.

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BP Set to Test New Cap

With a new, tighter fitting cap in place on the gushing Gulf wellhead , BP is preparing Tuesday to test whether the flow of oil could be stopped completely.

Kent Wells, a BP senior vice president, said a pressure test, which would allow for the valves on the cap to be closed thus completely shut down the leak, would probably start later Tuesday and last for six to 48 hours.

If the tests show the pressure rising and holding, which is an indication that the well is intact with no significant damage to the casing pipe that runs the length of the well below the sea floor, BP could decide to leave the valves closed, effectively cutting off the flow of oil.

However, if the tests show pressures that are lower than expected, said Wells, the well is damaged, meaning that oil and gas are leaking into the surrounding rock. If this is the case, then keeping the cap closed could damage the well further. The cap valves would have to be reopened, allowing oil to start escaping from the well again, although much of it would be funneled through pipes to surface ships.

Though the new cap could significantly help in efforts to contain the spill, the well will not be completely killed until relief wells are completed at the end of July or later.

EPA proposes new clean air regulations

The U.S. Environmental Protection Agency (EPA) has recently proposed new rules that would greatly reduce emissions of sulfur dioxide and nitrogen oxide that cross state lines.  The Clean Air Transport Rule, if adopted, will begin reducing emissions from power plants in 31 states and the District of Columbia by the year 2012.

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