May 3, 2011

Sales at generic drug maker Mylan increased by 12% during first quarter 2011, compared with first quarter 2010, the company said Tuesday.

May 3, 2011

The Food and Drug Administration has approved a generic version of Rogaine made by Perrigo, the drug maker said.

May 2, 2011

The Food and Drug Administration has approved a treatment made by Abbott for low testosterone in men, the drug maker said Friday.

May 2, 2011

The Food and Drug Administration has approved a new treatment for Type 2 diabetes, the agency said Monday.

April 29, 2011

The Food and Drug Administration has approved a new treatment for prostate cancer made by Johnson & Johnson.

April 27, 2011

A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

April 27, 2011

The Food and Drug Administration is working on creating new and simplified drug information sheets for consumers to replace the multipage and sometimes labyrinthine packets supplied with drugs at retail pharmacies, according to published reports.

April 27, 2011

An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.

April 26, 2011

The Food and Drug Administration has approved a new storage option for a hemophilia A treatment made by Bayer HealthCare Pharmaceuticals, the drug maker said.

April 26, 2011

The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.

April 26, 2011

Taro said that the Food and Drug Administration has declared the drug maker's manufacturing facility in Canada as having acceptable regulatory status.

April 25, 2011

Anglo-Swedish drug maker AstraZeneca has made the drug vandetanib available to certain thyroid cancer patients.

April 25, 2011

The Food and Drug Administration has approved the first vaccine for preventing meningococcal disease in children as young as 9 months old, the agency said.

April 25, 2011

A generic drug maker is being sued for patent infringement for its version of a fixed-dose combination drug co-created by Pozen and AstraZeneca.

April 25, 2011

SUPPLIER NEWS — Hi-Tech Pharmacal announced the tentative approval by the Food and Drug Administration of levofloxacin oral solution in the 25-mg/mL strength, a generic antibiotic. Levofloxacin oral solution is a generic version of Johnson & Johnson’s Levaquin, which had sales of $6 million in 2010, according to IMS Health. Hi-Tech expected to receive final approval in June, when Johnson & Johnson’s patent expires.


April 22, 2011

In response to a Food and Drug Administration warning letter, Tec Labs announced on Thursday that the company plans to work with the agency regarding its StaphAseptic first-aid antiseptic and pain-relieving gel.

April 21, 2011

The Food and Drug Administration on Wednesday issued four warning letters to companies that manufacture and market over-the-counter drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria, or MRSA.

April 21, 2011

GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

April 21, 2011

The Food and Drug Administration has approved a diabetes drug made by Lupin Pharmaceuticals, according to published reports.

April 21, 2011

Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

April 20, 2011

The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

April 20, 2011

Johnson & Johnson on Tuesday announced that distribution of McNeil Consumer Healthcare consumer products will slow in the coming months as the company shifts production of its over-the-counter medicines to other manufacturing plants and implements additional third-party quality controls within those plants.

April 20, 2011

The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

April 19, 2011

The main trade group for the generic drug industry is heralding a new cost analysis by the IMS Institute for Healthcare Informatics showing that generic drugs can reduce co-payments by up to 80%.