May 30, 2014 -- The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Damien Conover talks about emerging markets and the channels for pharmaceutical companies to succeed there. 

Damien Conover: When we look at the pharmaceutical landscape over the last few years, we’ve seen valuations improve significantly. A lot of this is being driven by three key areas. The first of which is the end of the patent cliff, which really peaked in the 2012 time period. The second point is the growing importance of emerging markets, which are offering a new channel of demand for pharmaceutical products.

Although a recall of a drug is never good news, we are happy to see Dr. Reddy do a voluntary recall to ensure the safety of patients. 

Article: 

Mumbai: Dr Reddy’s Laboratories Ltd is recalling 13,560 bottles of the high blood pressure drug metoprolol succinate in the US after it failed a dissolution test, the US Food and Drug Administration (FDA) said.

Metoprolol succinate extended release is a cheaper generic form of AstraZeneca Plc’s Toprol XL. Wockhardt Ltd also recalled 109,744 bottles of the same drug last month citing the same reason.

If this actually pans out on healthy people with low side effects...multi billion dollar drug!

Scientists used an arthritis drug to successfully grow a full head of hair on a 25-year-old man suffering from a non-curable disease.

Keeping GMP compliance in a changing world of regulation is tough. ASU has a range of courses in our Pharmaceutical Department that prepares you for the quality requirements of international agencies like the US-FDA.

GSK Canada in trouble: 

(Reuters) - A GlaxoSmithKline Plc plant in Canada that makes the flu vaccine Flulaval has been cited by the U.S. Food and Drug Administration for failing to meet quality control standards.

GSK said it is working to rectify the problems and does not expect a delay in distributing the vaccine for the 2014-2015 flu season. The company typically starts shipping the product at the end of July.

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