It adds that traces of a nonprescription drug
containing diphenhydramine, typically used to aid sleep, were found in both pilots.
The Act authorizes FDA to refuse admission of nonprescription drug
or dietary supplement products if (1) the label does not contain the name and domestic address or telephone number of the responsible person, (2) FDA has credible information indicating that the foreign manufacturer, packer, or distributor has not complied with the serious adverse event reporting requirements, or (3) the foreign manufacturer, packer, or distributor has not allowed FDA access to its records of adverse events.
PARSIPPANY, N.J.--While traditional nonprescription drugs
registered an average compound annual growth rate of 2.5% between 2005 and 2010, the market for natural over-the-counter remedies has grown at a rate of 5.9% per year from 2009 to 2011, according to a study by Kline & Co.
While sales of nonprescription drugs
rose by about 2.6% in 2006, according to Kline, Prilosec posted a 23% gain and helped lift the large antacid and antigas product category and show a 6.3% gain for the year.
"J&J's share of the Canadian over-the-counter market essentially doubled with the Pfizer acquisition, widening its lead on the next closest competitor, Wyeth, by more than $300 million [Canadian]," says Laura Mahecha, industry manager of the health care practice at Kline & Co., which has released a new report on nonprescription drugs
Zepharma was created in October 2004 through the integration of the nonprescription drug
divisions of Yamanouchi Pharmaceutical Co.
Astellas, meanwhile, has been seeking to sell Zepharma as it is difficult to expect strong growth in Japan's nonprescription drug
market, the sources said, adding it has also negotiated with other pharmaceutical makers on the possible sale of Zepharma.
Regionally, one-third of Europeans and 31% of North Americans agree that their nonprescription drug
usage will change, but in Latin America (47%), the Middle East/Africa (55%) and the Asia/Pacific region (57%) the levels are significantly higher.
With Wal-Mart in the picture, the nonprescription drug
dollar sales climbed 4.4% to $41.63 billion.
And last May Wal-Mart outlined a program in which it has paced more than 1,000 nonprescription drug
items--including such popular O-T-C products as Claritin, Pepcid and Zantac--at $4 or less.
The FDA's nonprescription drug
advisory committee is expected to consider whether loratadine, the active ingredient in Claritin, is appropriate for the O-T-C setting at a previously scheduled meeting on April 22 and April 23.
Pfizer was once a force in the nonprescription drug