FDA approves Teva’s generic Sarafem Pulvules
JERUSALEM The Food and Drug Administration has granted final to Teva Pharmaceuticals to market a drug for treating premenstrual dysphoric disorder.
The drug, fluoxetine, is a generic version of Eli Lilly’s drug Sarafem Pulvules. The FDA granted approval for Teva’s application for 10 mg and 20 mg capsules of the drug Wednesday. The FDA granted a first-to-file 180-day marketing exclusivity to Teva. The drug will ship immediately.
Teva, headquartered in Israel, is a manufacturer of generic drugs and one of the 20 largest pharmaceutical companies in the world. Teva North America operates in California, Missouri, Florida, New York, New Jersey and Pennsylvania.
Pfizer invests in FivePrime for diabetes, cancer treatments
SAN FRANCISCO Pfizer has taken an equity investment in FivePrime Therapeutics as part of a new research and licensing deal to find antibody targets and therapeutic protein products to treat diabetes and cancer, according to published reports.
FivePrime, a preclinical stage company expected to file an investigational new drug application for its lead oncology compound within the next six weeks, will receive an upfront payment and the equity investment from Pfizer. It also will get three years of committed research funding.
The deal is one of the first by Pfizer’s new Biotherapeutics and Bioinnovation Center. The center is trying to boost the company’s pipeline by acquiring companies with promising drug developments.
Pfizer will have exclusive worldwide rights to develop and commercialize certain products and targets that are discovered, while FivePrime will receive future milestone and royalty payments.
The deal helps FivePrime take several of its potential cancer products into clinical trials while expanding its discovery work, said president and chief executive officer Gail Maderis.
The companies did not disclose figures for those aspects of the deal.
H-E-B, Kraft partner to offer health screenings
NEW YORK H-E-B, the Texas grocery chain, will offer health screenings at all its pharmacies on the second Saturday of every month until October.
The “Second Saturday Health and Wellness Screenings” program is sponsored by Kraft and offers free glucose and blood pressure screenings, as well as discounts on lipid panel, A1C and cholesterol screenings. Customers will receive free samples of healthy products as well.
Each screening has a theme: children for June, the military for July, the beginning of the school year for August, fitness for September and wellness for October.