April 18, 2013

A federal court ruling has allowed Actavis to relaunch a generic contraceptive drug, the company said.

April 17, 2013

The Food and Drug Administration has approved a modification to a program added to the labeling of an obesity drug to ensure patient safety.

April 17, 2013

A Food and Drug Administration panel has recommended that the agency approve an experimental drug for chronic obstructive pulmonary disease made by GlaxoSmithKline and Theravance, the two companies said.

April 17, 2013

Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.

April 16, 2013

Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

April 16, 2013

The Food and Drug Administration has approved a new strength of an antibiotic made by Warner Chilcott, the drug maker said.

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 16, 2013

Amid various strategies adopted to stop the proliferation of rogue online pharmacies, one group has proposed controlling what they can put at the end of their Web addresses.

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%.

April 16, 2013

Two Dallas-based compounding pharmacies announced a recall of sterile drug products made at their facilities due to production conditions that could lead to contamination.

April 15, 2013

Generic makers heralded the fiscal year 2014 budget proposed last week by the Obama administration for its embrace of generic drugs, but were critical of its provisions on patent settlements and rebates.

April 15, 2013

The governor of North Dakota has signed into law a bill that would require pharmacy benefit managers to inform pharmacies about how reimbursement for generic prescription drugs is calculated under maximum allowable cost benchmarks and provide a more detailed appeals process to pharmacies to contest the MAC reimbursement caps that PBMs set up.

April 15, 2013

Vitamin D significantly reduces women's risks of developing uterine fibroids, according to a new study.

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 12, 2013

Celgene Corp. chairman and CEO Robert Hugin has been elected as chairman of a pharmaceutical industry trade group.

April 12, 2013

The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

April 12, 2013

An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

April 12, 2013

Early last week the National Advertising Division recommended that Bausch + Lomb modify or discontinue certain claims made in an advertorial context that refer to Alcon Laboratories' Opti-Free RepleniSH contact lens solution.

April 12, 2013

Healthcare accrediting organization URAC is calling for public comment on a new set of standards it has issued for accountable care, the group said.

April 11, 2013

Three Democratic lawmakers on Wednesday released a report that found inconsistencies in the labeling and classification of energy drinks, extensive marketing to adolescents and young adults through social media and events, and high caffeine levels that exceed what is considered safe in soda by the Food and Drug Administration.

April 11, 2013

Pharmavite on Wednesday announced receipt of the brand's official gluten-free certification across its SoyJoy line from the Gluten-Free Certification Organization.

April 11, 2013

QS/1 has released Medicare Part B compliance documentation, which it said would be the first of its type on the market to help pharmacies that want to serve Part B customers while remaining compliant, the company said.

April 11, 2013

The government of Canada's Alberta province will pay pharmacists $1 for each prescription filled as part of a one-year transition program for which it will spend $24 million, according to published reports.

April 10, 2013

Legislation designed to limit the use of biosimilars has met defeat in Maryland.