John Foraker, Annie's CEO, discusses why its consumers are interested in non-GMO products. "Lowering our guidance had nothing to do with genetically modified ingredients," he explains.» Read More
The suspension at the Toansa and Dewas plants, already banned by the U.S. Food and Drug Administration from shipping products to the United States, Ranbaxy's biggest market, will hit supplies to other key markets such as Europe and India, two people with direct knowledge of the matter said.
As one example, the FDA has sought to lower the dosage of painkiller acetaminophen from 500 milligrams in widely used products such as "extra strength" Tylenol to 325 mg, based on current knowledge of the liver damage the drug can cause.
For more information on the FDA's Advisory Committee meetings, see: http://www.fda.gov/AdvisoryCommittees/Calendar/default. htm. LOCATION: College Park Holiday Inn, Ballroom, 10000 Baltimore Ave., College Park, Md..
WASHINGTON, Feb 21- The U.S. Food and Drug Administration is proposing sweeping changes to its 40- year-old system for approving over-the-counter drugs to make it quickly adaptable to scientific changes. The FDA has scheduled a hearing for public comments on March 25 and March 26.
*FDA chief says important for India to work with foreign regulators. MUMBAI, Feb 18- The head of the U.S. Food and Drug Administration called for more collaboration among regulators to improve drug quality and safety as she wrapped up a visit to India after recent import bans on drugs from a handful of plants in the country.
MUMBAI, Feb 18- The U.S. Food and Drug Administration is working with Indian regulators to enhance the quality and safety of drugs made there, the FDA's Commissioner Margaret Hamburg said on Tuesday.
NEW YORK, Feb 14- U.S. health regulators have declined to approve proposed wider uses of Bayer AG and Johnson& Johnson's lucrative blood clot preventer Xarelto, the drugmakers said on Friday. An advisory panel to the FDA concluded in January that Xarelto should not be approved to prevent new heart attacks or strokes, a use referred to as secondary prevention.
Feb 14- The U.S. Food and Drug Administration denied an approval to a wider use of Johnson& Johnson's heart drug Xarelto. The blood-clot preventing drug is already approved for use in multiple indications.
*Panel votes 7-2 against drug's use during a heart procedure. Feb 12- An independent advisory panel to the U.S. Food and Drug Administration said a blood clot preventer developed by The Medicines Co should not be approved due to a lack of data to prove its efficacy. Medicines Co shares fell 12 percent to $29.05 in post-market trading.
Feb 12- An independent advisory panel to the U.S. Food and Drug Administration said a blood clot preventer developed by The Medicines Co should not be approved due to a lack of data to prove its efficacy. The panel voted 7-2 against approving the drug, cangrelor, for use during angioplasty- a heart surgery for widening narrow or clogged arteries.
Feb 12- U.S. health regulators on Wednesday approved the Johnson& Johnson and Pharmacyclics Inc cancer drug Imbruvica to treat chronic lymphocytic leukemia, a slowly progressing form of blood cancer. The Food and Drug Administration decision marks the second approval recently for the medicine, known chemically as ibrutinib.
Feb 11- An advisory panel to the U.S. Food and Drug Administration said on Tuesday that available evidence does not prove that the painkiller naproxen, sold under the brand names Aleve and Naprosyn, carries a lower cardiac risk than rival products.
Feb 11- An advisory panel to the U.S. Food and Drug Administration voted on Tuesday that there is not enough evidence to show conclusively that the painkiller naproxen carries a lower cardiac risk than other popular products.
Feb 11- The U.S. Food and Drug Administration said it will review possible heart risks associated with AstraZeneca Plc's widely-used diabetes drug saxagliptin, marketed as Onglyza and Kombiglyze XR.
Feb 10- U.S. Food and Drug Administration reviewers are divided on whether an intravenous blood clot preventer developed by The Medicines Co should be approved, news that sent the company's stock down more than 7 percent on Monday.
Feb 6- The U.S. Food and Drug Administration proposed a new rule to better regulate and set safety standards in the manufacture of infant formula products.
Margaret Hamburg, plans to visit India for the first time in an official capacity next week as the agency works to keep sub-standard food and drugs from entering the United States.
The attorney suing energy drink maker Monster, Kevin Goldberg of Goldberg, Finnegan and Mester, responds to Monster's statement claiming there is no evidence the drinks have caused or contributed to any injury whatsoever.
The $115 million campaign, to be overseen by the Food and Drug Administration, will target the 10 million young people aged 12 to 17 who are open to trying cigarettes or who are already experimenting with them and are in danger of becoming regular smokers, the FDA said.
Feb 4- The U.S. Food and Drug Administration rejected a migraine drug made by Israel's RedHill Biopharma Ltd and Canada's IntelGenx Corp.. The FDA raised questions about the third-party manufacturing process, as well as the packaging and labeling of the drug, called RHB-103, the companies said in a statement.