FDA approves Lupin generic contraceptive
MUMBAI, India — The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.
Lupin announced the approval of Daysee (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) in the 0.15-mg/0.03-mg and 0.01-mg strengths.
The drug is a generic version of Teva’s Seasonique. Various versions of the drug had sales of $161 million in 2012, according to IMS Health.
RxWiki launches beta version of mobile pharmacy app
AUSTIN, Texas — The makers of a new smartphone app say it will synchronize engagement between pharmacists and patients through mobile devices, social media, websites and printed media.
RxWiki announced Friday the beta release of Mobile+, a customizable mobile application that delivers medication information, news and alerts to patients’ smartphones. The app is currently available for Android devices and will soon be available for Apple devices.
"With millions of patients searching for health information on their smartphones, there is a major opportunity for pharmacists to connect with patients outside the pharmacy," RxWiki publisher and CEO Donald Hackett said. "RxWiki Mobile+ enables pharmacists to prescribe trusted information to patients on any digital device, at any time, wherever they are."
Features include integration of the pharmacy’s branding within the app, a touch-to-call option to dial the pharmacy’s telephone number and news feeds customizable by health condition.
According to Pew Internet research, 1-out-of-every-3 minutes spent online is on a smartphone, and research2guidance estimates that within two years, about 500 million people worldwide will be using healthcare mobile apps.
"The rapid adoption of mobile devices gives community pharmacists another opportunity to improve medication therapy management and reduce costs," Hackett said. "RxWiki’s Digital Pharmacist network members can ensure their patients receive trusted, consistent information throughout the medication delivery experience provided by RxWiki Mobile+."
Acadia Pharmaceuticals can apply for approval of Parkinson’s disease psychosis drug early
SAN DIEGO — The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson’s disease, meaning that it can cancel a planned late-stage clinical trial, the company said.
Acadia Pharmaceuticals announced that the FDA had allowed it to move forward in applying for approval of the drug pimavanserin for the treatment of Parkinson’s disease psychosis, or PDP, based on data from an already complete phase-3 trial and other data. The decision by the FDA means the company no longer perform another phase-3 trial that it had planned.
"We are very pleased with the outcome of our meeting with the FDA, which we expect will reduce substantially both the time and cost of our PDP development program," Acadia CEO Uli Hacksell said. "This represents another important step toward our goal of bringing pimavanserin to the market as an innovative therapy for Parkinson’s patients who suffer from the psychosis frequently associated with this disease."
Of the 1 million people in the United States with Parkinson’s disease, about 60% develop PDP, a condition that causes visual hallucinations and delusions, according to the National Parkinson’s Foundation. There is currently no FDA-approved treatment for PDP, Acadia said.