Content about Abbreviated New Drug Application

July 25, 2011
ReportersNotebook — Chain Pharmacy, 8/1/11

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 seeks to commercialize generic Avodart

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 receives final approval for generic Zantac 150

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 faces patent challenge over generic Vigamox

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

February 22, 2011
Prasco agrees to distribute authorized generic of Pentasa

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
Impax granted FDA approval for generic Adoxa

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
Auralgan otic solution seized by government officials

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
Report: Exclusivity period for biotech drugs may be reduced to seven years

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
Impax confirms patent challenge for generic Concerta

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

November 30, 2010
PwC survey sheds light on public confidence, misconceptions about the FDA

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 sued for patent infringement over generic Welchol

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
GPhA responds to possibility of more stringent FDA regulations

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

November 14, 2010
Reporters Notebook

K-V Pharmaceutical has created a new marketing subsidiary for generic drugs, the company said. K-V...

November 2, 2010
BIO, GPhA and Sandoz testify at FDA biosimilars hearing

The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of...

September 26, 2010
GPhA and FDA to discuss me-too medicines at technical conference

More than a dozen top Food and Drug Administration officials will meet with generic drug...

September 9, 2010
Sorry, FTC: 'Pay-for-delay' isn't going away

This week’s decision by the U.S. Second Circuit Court of Appeals could make political efforts...

August 30, 2010
Sigmapharm files ANDA for generic Hepsera

A generic drug maker has filed an abbreviated new drug application for its version of...

July 6, 2010
CVS Caremark study: Less-restrictive generic laws could curb state Medicaid costs

Changing generic substitution laws in favor of less-restrictive regulations could save states struggling to pay...

June 14, 2010
Intellipharmaceutics files new drug application for generic Protonix

Intellipharmaceutics has filed an abbreviated new drug application for a generic drug designed to treat...

June 2, 2010
Perrigo receives FDA approval for generic Monistat-1 Combination Pack

Perrigo on Thursday announced that it has received final approval from the Food and Drug...

March 1, 2010
Impax Labs receives FDA approval for generic tamsulosin

The Food and Drug Administration has approved the first generic version of a drug for...

January 31, 2010
Teva files ANDA for generic version of HIV drug

Teva is hoping to release its version of an HIV drug before the drug’s patents...

January 7, 2010
Watson files FDA application for generic LoSeasonique

Watson Labs, a subsidiary of specialty pharmaceutical company Watson Pharmaceuticals, has filed an abbreviated new...

January 5, 2010
Watson seeks FDA approval for sleep disorder treatment

Watson has filed an abbreviated new drug application for the generic version of a sleep...

June 28, 2009
FDA approves generic contraceptive pill

The approval of Watson Pharmaceutical’s ANDA for levonorgestrel tablets, otherwise known as the emergency contraceptive...

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