July 10, 2012

President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

July 5, 2012

The Food and Drug Administration is asking companies to stop manufacturing and distributing unapproved drugs containing the painkiller oxycodone, the agency said Thursday.

May 18, 2012

Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength.

April 23, 2012

Par Pharmaceutical has bought rights to a generic drug for gastroesophageal reflux disease from Handa Pharmaceuticals, Par said.

March 14, 2012

Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

February 9, 2012

The generic drug industry's main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.

January 23, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said.

January 20, 2012

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


December 12, 2011

Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.

November 4, 2011

In the classic “Arabian Nights” tale of Aladdin and his magic lamp, the evil sorcerer who made Aladdin retrieve the lamp containing the genie attempts to get it back by tricking Aladdin’s wife into giving it to him by roaming through the streets offering to trade “new lamps for old.”


September 13, 2011

Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

August 12, 2011

Watson Pharmaceuticals will build a drug warehouse and distribution center in Mississippi, the drug maker said Thursday.

July 25, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said.

June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

May 17, 2011

Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

April 8, 2011

Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

February 22, 2011

Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

February 18, 2011

A generic drug maker received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

February 17, 2011

The Food and Drug Administration has seized supplies of a drug used to treat ear infections, under a program the agency started to remove unapproved drugs from the market.

February 17, 2011

The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

November 30, 2010

A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

November 30, 2010

The spate of recent product recalls may be eroding consumer confidence in the Food and Drug Administration, according to a PricewaterhouseCoopers survey of 1,000 Americans released Tuesday.

November 22, 2010

Impax confirmed a patent challenge for its version of a branded cholesterol drug that recently was submitted to the FDA for approval ...

November 14, 2010

A ghost from 2008 soon could come back to haunt 2010....