September 10, 2012

A study of an experimental drug for insomnia indicated that patients who stop taking it continue having sleeping problems, according to results of a clinical trial announced Monday.

September 7, 2012

Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

September 6, 2012

Kalorama Information on Thursday reported that a number of Rx-to-OTC switch applications currently are under review by the Food and Drug Administration across several new-to-self-care categories, including overactive bladder, bacterial infections, cholesterol and high blood pressure.

September 5, 2012

The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.

September 5, 2012

The Food and Drug Administration will not decide whether to approve a drug for diarrhea in HIV patients as it continues to review the regulatory approval application for it, the drug's manufacturer said.

September 4, 2012

The Food and Drug Administration has approved a new drug made by Astellas Pharma U.S. and Medivation for treating prostate cancer, the agency said Friday.

September 4, 2012

The Food and Drug Administration has approved a new formulation of a cancer drug made by Novartis for a type of brain cancer in children, the agency said.

September 4, 2012

The Food and Drug Administration has approved a generic antidepressant made by Wockhardt, the Indian drug maker said Tuesday.

August 30, 2012

The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

August 28, 2012

The Food and Drug Administration has determined that generic drug maker Caraco is in compliance with relevant paragraphs of the consent decree and may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Mich., Caraco's parent company Sun Pharmaceutical Industries said.

August 27, 2012

Genzyme announced it has received a refuse-to-file letter from the Food and Drug Administration in response to the drug maker's supplemental biologics license application for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis.

August 24, 2012

The Food and Drug Administration has approved a generic medicated patch for treating pain made by Watson Pharmaceuticals, the company said.

August 23, 2012

A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.

August 23, 2012

The Food and Drug Administration has approved a generic drug for high blood pressure made by Wockhardt, the Indian drug maker said.

August 23, 2012

Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

August 9, 2012

Hospira has relaunched a generic chemotherapy drug for the U.S. market, the generic drug maker said Thursday.

August 9, 2012

Drug maker Sagent Pharmaceuticals has launched a generic chemotherapy drug, the company said Thursday.

August 8, 2012

Drug makers Teva Pharmaceutical Industries and Active Biotech will start a third late-stage clinical trial of an experimental drug for treating multiple sclerosis, the companies said Wednesday.

August 6, 2012

Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the company said Monday.

August 2, 2012

Use of generic drugs has saved consumers and the healthcare system $1 trillion over the past decade, according to a new study released Thursday by a generic drug industry trade organization.

July 31, 2012

AmerisourceBergen on Tuesday announced that it has signed a three-year agreement to supply approximately $18.5 billion in pharmaceuticals to Express Scripts on an annual basis.

July 30, 2012

Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.

July 18, 2012

The Food and Drug Administration has approved a new weight-loss drug made by Vivus, the agency said.

July 16, 2012

A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.