FILE - This July 19, 2002 file photo shows the Johnson & Johnson corporate headquarters in New Brunswick, N.J. The Food and Drug Administration on Monday, Dec. 31, 2012 approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades. (AP Photo/Daniel Hulshizer, File)
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FILE - This July 19, 2002 file photo shows the Johnson & Johnson corporate headquarters in New Brunswick, N.J. The Food and Drug Administration on Monday, Dec. 31, 2012 approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades. (AP Photo/Daniel Hulshizer, File)
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Dr. Mark Molitch of Northwestern University, who helped write medical standards meant to limit HGH treatment to legitimate patients, holds an injector pen that contains approximately a weeks worth of doses for a patient in need of the drug at his clinic Thursday, Dec. 20, 2012, in Chicago. An Associated Press investigation shows that a federal crackdown on illicit foreign supplies of human growth hormone has failed to stop rampant misuse, and instead has driven record sales of the drug by some of the world's biggest pharmaceutical companies. (AP Photo/M. Spencer Green)
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This photo shows an injector pen that contains approximately a weeks worth of HGH doses for a patient in need of the drug at the clinic of Dr. Mark Molitch of Northwestern University, who helped write medical standards meant to limit HGH treatment to patients in need of the drug Thursday, Dec. 20, 2012, in Chicago. An Associated Press investigation shows that a federal crackdown on illicit foreign supplies of human growth hormone has failed to stop rampant misuse, and instead has driven record sales of the drug by some of the world's biggest pharmaceutical companies. (AP Photo/M. Spencer Green)
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This image made available by Atria Books shows the cover of Dr. Jeffry Life's 2011 book "The Life Plan." Life used testosterone and human growth hormone in his own bodybuilding regimen. (AP Photo/Atria Books, Terry Goodlad)
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In this Tuesday, June 28, 2011 photo, agents with the Drug Enforcement Administration stand outside the Treasure Coast Pharmacy in Jensen Beach after a raid. shortly before it opened Tuesday morning as part of an ongoing investigation. DEA, the Florida Department of Health, Florida State Troopers, Martin County Sheriff's deputies and Boca Raton and Margate police participated in the investigation. (AP Photo/TCPalm.com, Alex Boerner) MANDATORY CREDIT: TCPALM.COM, ALEX BOERNER
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In this Nov. 21, 2012, photo, Melanie Norwood, left, sits next to her attorney, Mark Chalos, as she talks about her mother, Marjorie Norwood in Nashville, Tenn. Marjorie Norwood, 59, became sick with fungal meningitis after getting steroid shots produced by the New England Compounding Center. Federal lawsuits in five states have been filed against the New England Compounding Center by patients who received shots of steroid medication produced by the pharmacy and more are being filed in state courts every day. (AP Photo/Mark Zaleski)
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This undated family photo shows meningitis victim Marjorie Norwood in Nashville, Tenn. Norwood became sick with fungal meningitis after getting steroid shots produced by the New England Compounding Center. Federal lawsuits in five states have been filed against the New England Compounding Center by patients who received shots of steroid medication produced by the pharmacy and more are being filed in state courts every day. (AP Photo/Family Photo)
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In this Nov. 21, 2012, photo, Melanie Norwood talks about her mother, Marjorie Norwood in Nashville, Tenn. Marjorie Norwood, 59, became sick with fungal meningitis after getting steroid shots produced by the New England Compounding Center. Federal lawsuits in five states have been filed against the New England Compounding Center by patients who received shots of steroid medication produced by the pharmacy and more are being filed in state courts every day. (AP Photo/Mark Zaleski)
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In this Nov. 21, 2012, photo, attorney, Mark Chalos, right, sits with Melanie Norwood, left, as they talk about the condition of Norwood's mother, Marjorie Norwood, in Nashville, Tenn. Marjorie Norwood, 59, became sick with fungal meningitis after getting steroid shots produced by the New England Compounding Center. Federal lawsuits in five states have been filed against the New England Compounding Center by patients who received shots of steroid medication produced by the pharmacy and more are being filed in state courts every day. (AP Photo/Mark Zaleski)
FDA panel backs long-acting Boehringer inhaler
WASHINGTON (
AP) — A panel of federal health experts on Tuesday overwhelmingly recommended approval for a long-acting inhaler to treat people suffering from chronic lung disease.
The Food and Drug Administration panel voted 15-1, with one abstention, that Boehringer Ingelheim's once-daily Striverdi Respimat (STRIH-ver-dee Res-peh-mat) inhaler is safe and effective for chronic obstructive pulmonary disease, a condition that causes bronchitis and emphysema.
The disease affects about 24 million people in the U.S. and is most commonly caused by cigarette smoking. Symptoms include cough, phlegm and shortness of breath.
The FDA is not required to follow the guidance of its panels, though it often does.
German drugmaker Boehringer is also asking the agency to approve the drug, known chemically as olodaterol, with labeling stating that it increased patients' ability to exercise. If approved, the drug would be the first inhaler with that claim.
Boehringer studied the drug in patients for up to 48 weeks, measuring their lung capacity based on volume of air they could expel.
"The positive vote from the advisory committee marks an important step towards making olodaterol available," said Boehringer vice president Tunde Otulana in a statement.
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