Lannett gets PDUFA date for morphine sulfate oral solution
PHILADELPHIA — Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett’s drugs.
The FDA said it revised its PDUFA goal date of June 23 for Lannett’s new drug application for morphine sulfate oral solution.
"With a revised PDUFA date in 17 days, we are preparing for the relaunch of our morphine sulfate oral solution product, if approved,” Lannett president and CEO Arthur Bedrosian said.
Dr. Reddy’s gets OK for three drugs
HYDERABAD, India — Dr. Reddy’s Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer’s disease, depression and breast cancer.
The drug maker said that the FDA approved donepezil hydrochloride tablets, a generic version of Pfizer and Eisai’s Arciept, in the 5-mg and 10-mg strengths for the treatment of Alzheimer’s disease. Both strengths will be available in 30-, 90- and 500-count bottles.
Dr. Reddy’s also said that the FDA approved its venlafaxine hydrochloride extended-release capsules in the 37.5-mg, 75-mg and 150-mg strengths. The drug is a generic version of Effexor XR capsules, a depression and anxiety treatment made by Wyeth, which now is owned by Pfizer.
What’s more, the drug maker also said that its letrozole tablets USP in the 2.5-mg strength, a generic version of Novartis’ breast cancer drug Femara, will be available in 30-count bottles.
Dr. Reddy’s said its abbreviated new drug applications for Aricept and Effexor XR were approved in May, while the company’s ANDA for letrozole tablets was approved last week.
Topaz seeks FDA approval for head lice treatment
HORSHAM, Pa. — The Food and Drug Administration has accepted a regulatory approval application for a head lice treatment made by Topaz Pharmaceuticals, Topaz said Tuesday.
Topaz is seeking approval for ivermectin topical cream, for treating head lice in children and adults.
“This filing represents the transition of the company from the development phase as we are now preparing to commercialize our lead product candidate,” Topaz president and CEO Robert Radie said. “Current treatment options are limited by one or more of safety, efficacy and convenience issues. We believe there is an unmet need to provide a new option for the more than 6 million people, mostly school-aged children, who are impacted by lice each year in the United States.”