April 16, 2013

Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

March 14, 2013

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

February 28, 2013

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

December 28, 2012

Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

December 10, 2012

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

October 23, 2012

The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

October 17, 2012

The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

October 16, 2012

Par Pharmaceutical Cos. has entered into agreements with Watson Pharmaceuticals and Actavis to purchase five generic products currently marketed in the United States by Watson or Actavis, eight abbreviated new drug applications currently awaiting regulatory approval, and a generic product in late-stage development.

October 16, 2012

Perrigo has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application to market over-the-counter omeprazole and sodium bicarbonate capsules in the 20-mg/1,100-mg strength, the store-brand equivalent to Merck's Zegerid OTC.

October 2, 2012

Drug makers Takeda Pharmaceutical and H. Lundbeck have applied with the Food and Drug Administration for a new drug to treat depression in adults.

August 29, 2012

The Food and Drug Administration has granted priority review to a supplemental new drug application for a drug developed by Janssen Research and Development.

August 22, 2012

The Food and Drug Administration has postponed its decision whether or not to approve an experimental arthritis drug made by Pfizer, the drug maker said.

July 6, 2012

The Food and Drug Administration has accepted a new drug application for a low-dose, once-weekly contraceptive patch from Agile Therapeutics, the drug maker said.

June 22, 2012

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

June 22, 2012

The Food and Drug Administration has issued a complete response letter regarding a supplemental new drug application for a medication developed by Janssen Research and Development.

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.