Perrigo, Synthon to launch generic Xyzal
ALLEGAN, Mich. — The Food and Drug Administration has granted market exclusivity for a generic version of a medication designed to treat indoor and outdoor allergies.
Perrigo said Monday that its licensor and supplier Synthon received regulatory approval for levocetirizine tablets, a generic version of UCB/Sepracor’s Xyzal, which is marketed in the United States by Sanofi-Aventis.
The levocetirizine tablet is the only approved generic product having a label containing all indications, Perrigo said.
Merck’s president steps in as new CEO
WHITEHOUSE STATION, N.J. — The president of drug maker Merck now will fill an additional position at the company: CEO.
Merck’s board of directors elected president and board member Kenneth Frazier as the company’s next leader, effective Jan. 1. Frazier will succeed Richard Clark, who has served as Merck’s CEO since 2005. Clark will continue as chairman of the board, the drug maker said.
Frazier’s career at Merck spans 18 years. Since becoming president, he has focused on improving the effectiveness of the company’s three largest divisions –– pharmaceutical and vaccine sales and marketing, research and development, manufacturing and supply –– and their post-merger integration, the drug maker said. Merck merged with Schering-Plough in a $41.1 billion deal in 2009.
PwC survey sheds light on public confidence, misconceptions about the FDA
NEW YORK — The spate of recent product recalls may be eroding consumer confidence in the Food and Drug Administration, according to a PricewaterhouseCoopers survey of 1,000 Americans released Tuesday.
Approximately one-half of respondents reported they think the FDA does a good job, but more than one-third (36%) of U.S. consumers said they have lost confidence in the FDA over the past two years as a result of high profile safety concerns and product recalls.
The lay public also has no appreciation for the time and costs invested in bringing a new drug to market, according to the survey. Slightly more than half (54%) of respondents think it takes only five years or less to develop a new drug or medical device, when it in fact can take up to 12 years in research and development and costs well in excess of $1 billion.
As many as 72% of respondents have confidence that the FDA monitors product safety after products are approved and are being sold to the public, though 28% are not confident.
And while the majority of U.S. consumers (93%) have confidence in the safety and effectiveness of drugs and medical devices approved for use in the United States, and two-thirds agree that the U.S. has the highest standards in the world for drug safety and effectiveness, more than half (56%) would be willing to use drugs and devices not approved by the FDA but approved elsewhere.