There's a huge backlog at the FDA's OGD, which has seen the number of submitted applications increase by 150 percent

According to the FDA, fewer generics are being approved for two reasons:

A shortage of personnel

and the number of faulty applications that generic companies submit.

OGD needs up to 100 more employees over the next three years to eliminate the build up--a move that would cost between $16 million and $19 million a year.

More funding to the Office of Generic Drugs (OGD) seems to be more logical option to improve adminstrative efficiencies.

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.

"Authorized generic drugs" are generic drugs from branded companies. Aka copycat version of their own brand drug. You will be wondering why do they (brand companies) do that. This way branded companies still make money even though their patent expires.

The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.

Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

The U.S. Food and Drug Administration [(FDA)] today announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. Trasylol, also known as aprotinin, works by blocking enzymes that dissolve blood clots. It is designed to stem blood loss and enable patients receiving heart bypass surgery to avoid transfusions.

FDA Announces Revisions to Labels for Cialis, Levitra and Viagra - The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing. [FDA]

The FDA approved Armodafinil (Nuvigil®) on June 18, 2007 for the treatment of excessive sleepiness due to sleep apnea, narcolepsy or shift-work disorder (SWSD). Armodafinil (Nuvigil®) is an stimulant

Indianapolis-based Eli Lilly and Co. says it has settled an additional 900 product liability lawsuits, four of which were scheduled to go to trial in July, which alleged that the firm did not adequately

 Zheng Xiaoyu, former State Food and Drug Administration (SFDA) of China was sentenced to death on charges of corruption and official negligence.

Zheng Xiaoyu was convicted for taking bribes

Purdue has now acknowledged that it illegally promoted OxyContin by falsely claiming that it was "less addictive, less subject to abuse and diversion, and less likely to cause withdrawal symptoms than other pain medications - all in an effort to maximise its profits" .

 The Federal Court of Appeal of Canada in Toronto has blocked Teva's Novopharm  to launch its form of Celebrex in Canada according to Pfizer statement on May 1st  .

This ruling will prevent Teva Pharmaceutical Industries Ltd. from launching a copycat form of its Celebrex arthritis drug in the country until 2014.