FDA approves first generic from Vitruvias Therapeutics, Sunny Pharmtech
SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic from Taiwan-based drug development company Sunny Pharmtech and generic development company Vitruvias Therapeutics. The companies announced the approval of its generic lidocaine ointment, 5%.
“We are pleased to have received such a timely approval with our first jointly filed application,” Sunny Pharmtech CEO and chairperson Yon-Lian Wu said. “It is a testament to competence and capabilities of both companies’ development and regulatory groups that our first application was approved so quickly.”
The generic is the first drug approved under the two companies’ joint development agreement that includes eight products.
“It is very exciting to receive our first joint approval, and we are looking forward to beginning the commercial phase of our business plan,” Vitruvias GM Carl Whatley said. “This approval represents our transition from a purely developmental company to one that can discover, develop and commercialize technically complex generics."
FDA takes aim at online pharmacies
SILVER SPRING, Md. — Working with international law enforcement agencies and regulators, the Food and Drug Administration recently acted against some 500 websites selling illegal and unapproved versions of such prescription drugs as opioids, epinephrine injections and antibiotics directly to American patients.
“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances,” FDA commissioner Dr. Scott Gottlieb said. “Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk by individuals who put financial gains above patient safety.”
The actions —including warning letters to the operators of targeted sites and the confiscation of certain websites in partnership with internet registrars — were part of Operation Pangea X, led by Interpol as part of the 10th International Internet Week of Action, which seeks to combat the illegal online sale and distribution of possibly counterfeit or substandard medical products.
“The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country,” Gottlieb said. “Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids.”
As part of the agency’s broader effort to fight illegal online pharmacies, Gottlieb said the FDA is developing a comprehensive Enforcement Operations Work Plan aimed at combating foreign unapproved drugs being sold to U.S. consumers and increasing the scope of the agency’s operations related to these operations.
Cardinal Health’s Giacomin re-elected as HDA board chairman
ARLINGTON, Va. — The Healthcare Distribution Alliance will be retaining Cardinal Health pharmaceutical segment CEO as its board chairman. The organization on Tuesday announced Jon Giacomin’s re-election to the position he has served in since 2016. Also continuing in his position on the board is vice chairman Henry Dale Smith, Jr., who is chairman and CEO of Smith Holding Co.
“HDA is pleased to welcome back Jon and Dale —their steady leadership will help shape the Alliance’s efforts to promote the critical role of pharmaceutical distributors, whose expertise ensures the safety and efficiency of the supply chain every day,” HDA president and CEO John Gray said.
In addition to Giacomin’s and Smith’s re-election, HDA appointed three new members — HPC Rx CEO Fred Battah, CuraScript SD president Earl English and Principal Dynamics CEO and Quality Care Products CEO Michael Holmes.