Content about FDA

WHITE PLAINS, N.Y. — Syneron Beauty entered the oral care category last year with its Tanda Pearl Ionic Teeth Whitening System and now, Syneron Beauty has created the Pearl brand. Enter Pearl Brilliant White Ionic Teeth Whitening system — the first new, at-home teeth whitening technology to be cleared by the FDA in more than a decade, according to the company.

In a clinical study, the system was shown to whiten up to 10 shades after 50 minutes.

WASHINGTON — The Justice Department late Wednesday reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.

NEW YORK — Syneron Beauty has announced the launch of the Pearl Brilliant White Ionic Teeth Whitening system, which according to the manufacturer, features its patented ionic technology — the first new at-home teeth whitening technology to be cleared by the FDA in more than a decade.

In a clinical study, the system was shown to provide maximum whitening results of up to 10 shades after 50 minutes of treatment with virtually no sensitivity, the company stated.

WASHINGTON — Sens. Bob Casey, D-Pa., and Lisa Murkowski, R-Ark., on Friday introduced the Preventing Abuse of Cough Treatments Act of 2013, which would require retailers to restrict the sale of dextromethorphan-containing products to adults. The bill also would restrict the sale of raw, bulk DXM to FDA-approved entities. 

Many retailers have age restrictions on the sale of DXM products already in place; and similar legislation to this has been enforced in California since 2012. 

WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

ATLANTA — SoloHealth on Thursday announced it has been selected as one of the Technology Association of Georgia’s Top 10 Innovative Technology Companies. SoloHealth was recognized for its FDA-approved health and wellness kiosk, the SoloHealth Station.

"The Top 10 awards are given to an elite group of companies whose products and solutions are not only changing their respective industries, they also are putting Georgia on the map as a state where technology innovation can thrive," stated Tino Mantella, president & CEO of TAG. 

NEW YORK — Mustela, a European skin care and stretch marks brand, recently introduced three products in a sun care range for babies.

The new Broad Spectrum SPF 50+ Mineral Sunscreen Lotion and Broad Spectrum SPF 50+ Mineral Sunscreen Stick are tested under the most recent FDA requirements for sunscreen and have both been awarded the Melanoma International Foundation’s Seal of Approval, the company stated.


Mustela’s formulations are 100% mineral, with naturally derived sunscreen filters titanium dioxide and zinc oxide.



MCLEAN, Va. — Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

While much attention on medication adherence has focused on patients not taking the already approved drugs prescribed to them or not taking them properly, the new study, released Tuesday by Consumer Health Information, found problems with adherence in clinical trials as well.

NEW BRUNSWICK, N.J. — Johnson & Johnson expects to return about 75% of its OTC brands to the marketplace over the course of 2013, Alex Gorsky, J&J chairman and CEO told analysts Tuesday. "I’m very pleased with the progress that we’re making in that," he said. "We mentioned to you that the consent decree that we had designed in conjunction with the FDA was approved and reviewed in October, with very few comments. And given the breadth and scale of that agreement, we felt very good about that. We’ve had teams working hard since then.

SILVER SPRING, Md. — The Food and Drug Administraiton has approved a treatment for replacing clotting proteins in the blood for conditions in which patients have too little of them.

The FDA announced the approval of Octapharma's Octaplas, a sterile, frozen solution of pooled human plasma from multiple donors that has been treated with a solvent detergent process.

LAS VEGAS — iHealth Labs on Monday unveiled two new additions to its suite of devices — the iHealth Wireless Smart Gluco-Monitoring System and iHealth Pulse Oximeter — at the 2013 Consumer Electronics Show here. 

SILVER SPRINGS, Md. — Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.