logo
Share SHARE
FONT-SIZE Plus   Neg

Teva Says FDA Decides Its Unit Is Sole First-to-file On Provigil - Quick Facts

Teva Pharmaceutical Industries Ltd. (TEVA: Quote) on Thursday said the FDA has decided that its wholly owned subsidiary, Teva Pharmaceuticals USA, is sole first-to-file for both Orange Book patents listed for Provigil (modafinil) and therefore Teva's ANDA alone is entitled to 180-day exclusivity.

Cephalon launched generic Provigil on March 29 and the FDA has also decided that such launch triggered the exclusivity.

Teva expects Par Pharmaceutical to launch a second generic product on April 6 pursuant to the agreement with the FTC in connection with the Cephalon acquisition.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Online retail giant Amazon.com Inc. (AMZN) is reportedly in talks to buy luxury online fashion retailer Net-a-Porter. The news of acquisition was first reported by Women's Wear Daily, which said the deal would be completed for about 2 billion euros, indicating the biggest acquisition yet by Amazon.... Tim Cook, the CEO of tech giant Apple Inc., in an interview said he intends to give away all his wealth to charity. Cook, in an interview to Fortune, said he plans to donate all his wealth to philanthropic projects after paying for his 10-year old nephew's college education. According to Fortune,... Is it a 'personal life crisis' that led the Germanwings' co-pilot Andreas Lubitz to deliberately lowering the plane carrying 149 people to French Alps mountain? Police is investigating to find evidences to prove this suggestion.
comments powered by Disqus
Follow RTT