Attention deficit hyperactivity disorder drugs like Ritalin have been on the FDA shortage list for a variety of reasons. Now add to that packaging problems which have led Novartis to recall nearly 22,000 bottles.
Teva Pharmaceutical Industries is one of half a dozen drugmakers that have been rolling out generics of Eli Lilly's top-selling blockbuster Cymbalta. The others are going to roll past the Israeli drugmaker after it recalled more than 1 million bottles of the antidepressant.
Tivicay, a combo HIV drug from GlaxoSmithKline, Pfizer and Shionogi that is pegged to become a blockbuster, was only approved last summer, but the companies are having to recall a small portion of it because of cross-contamination.
Rapidly expanding Indian generic drugmaker Lupin has stumbled, having to recall 5 lots of the antibacterial med Suprax (cefixime) because it failed purity tests.
Sun Pharmaceutical execs acknowledge it will be no easy task to repair Ranbaxy Laboratories' damaged reputation with the FDA and the public. But Sun managing director Dilip Shanghvi and his lieutenants came in with a laundry list of actions to be taken quickly to jump-start the process, sources tell Reuters.
The market may do what regulators around the world have been unable to achieve so far: It may make quality and consistent supply the focus for generics buyers over price.
Usually, it's the smaller drugmakers that take advantage of opportunities that present themselves when manufacturing problems arise at another company. But Novartis CEO Joe Jimenez is not above trying to drum up some business for his Sandoz generic drug unit by pointing out problems with some of the big drugmakers in India.
With FDA bans of products from some of India's largest drugmakers has come growing debate about the quality of drugs shipped to the U.S. Now sampling by the Drug Controller General of India since December 2012 has found that about 2.3% of products tested failed to meet standards.
For years the FDA has been trying to level the playing field in terms of foreign versus domestic drug manufacturing plant inspections. It wasn't many years ago when U.S. facilities could expect a visit every 30 months while foreign plants would go 5 or more years between inspections. One way to achieve parity is to cut the number of U.S. inspections while doing more overseas, and that is what the FDA proposes to do.
A contractor has tripped up Shire, which is voluntarily recalling three lots of its Gaucher drug Vpriv after finding stainless steel particulate in a small number of vials of the injected drug. The drugmaker said the problem was traced to the company handling the fill finish for Shire.