News

FDA gives tentative approval to generic hypertension drug

BY Alaric DeArment

MORRISTOWN, N.J. — Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

The company said the FDA had given tentative approval to guanfacine extended-release tablets in the 1-mg, 2-mg, 3-mg and 4-mg strengths, a generic version of Shire’s Intuniv. Tentative approval means a generic drug meets the basic regulatory requirements for final FDA approval, but the FDA can’t approve it because the patents covering the branded version have not yet expired. Actavis said it was likely the first company to file an application for generic Intuniv with a paragraph IV certification, a legal assertion that one or more patents covering Intuniv are invalid, unenforceable or not in danger of being infringed.

Intuniv had sales of about $342 million during the 12-month period ended in March, according to IMS Health.


Interested in this topic? Sign up for our weekly DSN Collaborative Care e-newsletter.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

POLLS

Which area of the industry do you think Amazon’s entry would shake up the most?
News

Theodent ‘chocolate’ toothpaste takes home Red Dot International design award

BY Antoinette Alexander

NEW ORLEANS — Emerging biotech company Theodent has received the Red Dot International design award for the innovative product design of its “chocolate toothpaste.”

Theodent’s rich brown and copper-colored box and tube — which recently garnered the cover of Tube News magazine — caught the eyes of the international design panel, which scrutinized 6,823 product entries from 43 countries. Theodent’s packaging was inspired by the company’s proprietary chocolate extract, Rennou, which is the active ingredient in the fluoride-free toothpaste that launched earlier this year in 171 Whole Foods Markets nationwide.

This is the first time that a toothpaste has been awarded the Red Dot for product design and innovative concept.

Theodent executives head to Berlin on Oct. 24 to accept the Red Dot award. Theodent will also celebrate the coveted win at the 2012 Red Dot design awards gala. In addition, Theodent will receive a two-page spread in the Red Dot "International Yearbook of Communication Design 2012/2013" (the official winners exhibition book), and will be prominently featured in the Red Dot museum of international design in Shanghai.

"We are truly humbled and honored that the international jury took note of Theodent’s unique tube design and packaging. We spent two years in the product and prototype development phase and that clearly paid off," stated Theodent president and CEO Arman Sadeghpour.

With this award, Theodent joins the industrial design ranks of Apple, Mercedes-Benz, Flos, Audi, Droog, BMW and B&B Italia to name a few.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

POLLS

Which area of the industry do you think Amazon’s entry would shake up the most?
News

Coca-Cola celebrates London 2012 Olympic Games with latest campaign

BY Allison Cerra

ATLANTA — Coca-Cola is giving fans a chance to get an insider’s look at Team USA through its London 2012 Olympic Games campaign.

As part of the campaign, Coca-Cola has rolled out limited-edition packaging for its beverages. The specially designed cans and fridge packs showcase action-shot silhouettes of Coca-Cola 8-pack of athletes, including: David Boudia (diving); Henry Cejudo (wrestling); Marlen Esparza (boxing); John Isner (tennis); Shawn Johnson (gymnastics); Jessica Long (paralympic swimming); Alex Morgan (soccer) and David Oliver (track and field). The athletes also are highlighted in eight new ads, which have debuted across the networks of NBCUniversal.

The campaign also is supported with online engagement and promotions; a Coca-Cola Times Square billboard that will feature fans’ photos and messages, which will debut on July 18; and more. Additional information can be found on Coca-Cola’s website.

"The new work captures the individual stories of support of our athletes on their Olympic journeys," said Katie Bayne, president and general manager of sparkling beverages at Coca-Cola North America. “Just like Coke, the energetic stories are all about patriotic optimism.”

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

POLLS

Which area of the industry do you think Amazon’s entry would shake up the most?