US Marshals seize Auralgan Otic Solution
In mid February, US Marshals acting on a request of FDA seized all lots of Auralgan Otic Solution from Integrated Commercialization Solutions in Brooks, Ky.
In mid February, US Marshals acting on a request of FDA seized all lots of Auralgan Otic Solution from Integrated Commercialization Solutions (ICS) in Brooks, Ky. Auralgan, a prescription drug used to treat pain and inflammation associated with ear infections, was manufactured by Deston Therapeutics located in Chapel Hill, N.C. and warehoused by ICS.
This action is part of FDA’s Unapproved Drugs Initiative, established in 2006 to get unapproved drugs either approved or off the market.
“The FDA is committed to taking enforcement action against companies marketing drugs that do not meet federal standards for safety, effectiveness, and quality,” said Deborah M. Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “We will remain vigilant in our efforts to protect consumers from unapproved products.”
Deston’s sale of Auralgan was not approved by FDA and its labeling did not include adequate directions for use. FDA repeatedly warned Deston last year that Auralgan was an unapproved new drug and that the company was violating the Federal Food, Drug, and Cosmetic Act by continuing its distribution. The value of Auralgan seized is estimated to be $16.5 million.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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