FDA sends warning letter to Actelion: Tracleer claims not supported
SILVER SPRING, Md. The Food and Drug Administration has delivered a warning letter to South San Francisco, Calif.-based Actelion Pharmaceuticals Monday, saying that the company made an unsubstantiated claim that the drug Tracleer is superior to other drugs.
The FDA said a flash card for Tracleer (bosentan) tablets omitted information, making its superiority claim unsubstantiated, while also admitting important information about the risks associated with the drug.
This misbranded the drug under the Federal Food, Drug and Cosmetic Act, wrote Thomas Abrams, director of the FDA’s Division of Drug Marketing, Advertising and Communications. The drug is approved for treating pulmonary arterial hypertension.
“These violations are concerning from a public health perspective because they suggest that Tracleer is safer and more effective than has been demonstrated,” Abrams wrote in the letter.
Abrams requested a written response to the letter by Dec. 9 and ordered Actelion to stop distributing the flash cards.
J&J announces tender offer to buyout Omrix Biopharma stock
NEW BRUNSWICK, N.J. Johnson & Johnson said Tuesday that it would be making a tender offer to purchase all outstanding shares of common stock of New York-based biotech Omrix Biopharmaceuticals in an offer worth about $438 million in cash.
Upon the successful closing of the offer, Omrix stockholders will receive $25 per share of Omrix common stock tendered in the offer, minus required holding taxes. Omrix will operate as a stand-alone company reporting through Johnson & Johnson subsidiary Ethicon.
J&J said it would file a tender offer statement with terms of the offer with the Securities and Exchange Commission. The offer will expire at midnight on Dec. 23.
CVS Caremark, MinuteClinic working overtime to disseminate flu shots
WOONSOCKET, R.I. CVS Caremark is working toward its previously announced goal of delivering one million flu vaccinations this year and as part of that effort has kicked off an advertising campaign to inform consumers about CVS Caremark’s integrated flu vaccination offerings, not to mention drive awareness of the MinuteClinic model.
The “Flu Shots Made Simple” campaign began in September and will run through Dec. 31. It is a multi-faceted campaign that includes in-store signage and store radio spots, a national television campaign promoting joint CVS/pharmacy and MinuteClinic flu shot services, a MinuteClinic-dedicated TV campaign in select markets, newspaper ads in select markets, direct mail to target consumers and public relation efforts.
The goal: To inform consumers about CVS Caremark’s integrated flu vaccination offering which includes MinuteClinic locations, pharmacist-administered shots and scheduled flu shot clinics within select CVS/pharmacy locations.
“Flu shots have always been a key service of CVS and MinuteClinic. We had the opportunity this year to align MinuteClinic’s flu shot capabilities with other flu vaccination services offered at CVS/pharmacy. It is a natural point of integrated services within CVS Caremark,” said Melissa Studzinski, director of marketing for MinuteClinic.
While the campaign runs through Dec. 31, flu shots will continue to be available at all 559 MinuteClinic locations on demand throughout the flu season, which could run as late as March or April.
As part of the campaign, the company has created a flu shot voucher program for Caremark clients whereby participating members are eligible to receive a flu shot at MinuteClinic with no out-of-pocket cost to them, noted Studzinski.