Content about New Drug Application

June 19, 2012

The Food and Drug Administration has declined to approve a drug designed to treat a rare, progressive and fatal neurodegenerative disease.

June 13, 2012

Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

June 11, 2012

Avanir Pharmaceuticals confirmed that the Food and Drug Administration has accepted the company's investigational new drug application for an Alzheimer's disease drug.

May 29, 2012

An experimental drug made by Pfizer for a rare and fatal neurodegenerative disease got a favorable vote from a Food and Drug Administration expert panel.

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.

May 2, 2012

The Food and Drug Administration has approved a generic drug for epilepsy made by Acella Pharmaceuticals, the company said Wednesday.

February 23, 2012

The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

February 13, 2012

Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.

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.


January 3, 2012

The Food and Drug Administration's Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.

December 21, 2011

Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

December 20, 2011

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

November 28, 2011

A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

November 10, 2011

The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

November 2, 2011

The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

October 28, 2011

The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

October 27, 2011

A company focused on developing niche generic and specialty pharmaceutical products has received regulatory approval from the Food and Drug Administration for its version of a psychiatric drug.

October 25, 2011

Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

October 20, 2011

Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

October 11, 2011

The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths.

September 28, 2011

Chelsea Therapeutics International has applied for Food and Drug Administration approval of a drug for a disorder that affects patients with diseases like Parkinson's disease.

September 7, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

September 1, 2011

The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

August 30, 2011

The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

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