April 13, 2011

The Food and Drug Administration has accepted a regulatory approval application for a topical treatment for low testosterone made by Teva Pharmaceuticals and BioSante Pharmaceuticals, BioSante said Wednesday.

April 13, 2011

A Food and Drug Administration expert panel has given a favorable vote to a drug made by Pfizer for tumors, Pfizer said Tuesday.

April 12, 2011

Perrigo on Tuesday announced that the Detroit office of the Food and Drug Administration has concluded its re-inspection of Perrigo's Allegan facility.

April 12, 2011

The Food and Drug Administration has approved a treatment made by Merck for treating skin cancer, Merck said Monday.

April 11, 2011

Another generic drug maker is seeking to market its version of a popular opioid painkiller.

April 11, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

April 11, 2011

The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

April 8, 2011

The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.

April 8, 2011

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

April 7, 2011

The Food and Drug Administration has approved a drug made by AstraZeneca for treating a rare form of thyroid cancer, the agency said.

April 7, 2011

U.S. marshals have seized more than $6 million in products distributed by Triad Group at the company’s facility in Hartland, Wis., the Food and Drug Administration reported Wednesday.

April 7, 2011

The Food and Drug Administration on Thursday posted a notification to healthcare professionals and patients that the agency continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products, which are available as a spray, gel and liquids sold over the counter.

April 7, 2011

The Food and Drug Administration has approved a drug made by GlaxoSmithKline and Xenoport for treating restless legs syndrome, the agency said Thursday.

April 6, 2011

The Center for Healthcare Supply Chain Research, the research foundation of the Healthcare Distribution Management Association, on Tuesday released “Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain,” the first comprehensive research study analyzing the impact of REMS programs across the healthcare supply chain.

April 5, 2011

The Food and Drug Administration Tuesday unveiled its easier-to-use search engine for consumers that are concerned about food and other product recalls.

April 5, 2011

Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

April 5, 2011

The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

April 4, 2011

Canadian drug maker Intellipharmaceutics International is seeking approval for a generic version of a treatment for mental disorders.

April 4, 2011

The Food and Drug Administration has approved a generic drug made by Mylan that reduces pressure in the eye, Mylan said Monday.

April 4, 2011

A drug used to treat pain in cancer patients now is available in the United States.

April 1, 2011

An investigational drug for Parkinson’s disease was safe and effective, according to results of a late-stage clinical trial scheduled for presentation next week.

April 1, 2011

The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

March 31, 2011

Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

March 31, 2011

Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.