May 6, 2013

The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.

May 2, 2013

Drug makers Boehringer Ingelheim and Eli Lilly have started a campaign designed to educate healthcare professionals about the role a type of protein plays in maintaining blood-sugar balance.

April 16, 2013

The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said.

April 12, 2013

The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

April 4, 2013

The Food and Drug Administration approval this week of a generic genital herpes ointment made by Mylan could make a slight dent in the stock price of the company that makes the branded version.

April 3, 2013

The Food and Drug Administration has approved a new drug for allergies in children made by Tris Pharma, the drug maker said.

March 29, 2013

The Food and Drug Administration has approved a new drug made by Johnson & Johnson for treating Type 2 diabetes, the agency said.

March 27, 2013

The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

March 27, 2013

The Food and Drug Administration has approved a new treatment for multiple sclerosis made by Biogen Idec, the agency said.

March 5, 2013

Drug maker Actavis is challenging the patent for a drug used to treat testosterone deficiency or absence in men, the company said.

March 1, 2013

The Food and Drug Administration has approved a once-monthly treatment for schizophrenia.

February 22, 2013

The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said.

February 14, 2013

The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

February 6, 2013

The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

January 28, 2013

The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.

January 25, 2013

Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area.

January 22, 2013

The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

January 16, 2013

The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

January 9, 2013

One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

December 28, 2012

Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

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 28, 2012

Mylan on Friday announced that its partner Famy Care has received final approval from the Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol Tablets USP in the 0.15mg/0.03mg strength.

December 18, 2012

Drug maker Merz Pharmaceuticals is suing Par Pharmaceutical over the latter's attempt to market a generic drug for cerebral palsy patients, according to published reports.

November 15, 2012

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.