Generic drugmaker Mylan ($MYL), impatient that money is sitting on the table, has sued the FDA to try to snatch the rights to produce a generic of Novartis' ($NVS) blockbuster blood pressure med, Diovan.
Ranbaxy Laboratories is investigating whether splintered glass from the lining of a reactor at a plant in India is the source of particles found in the raw ingredients for generic Lipitor that were delivered to a Ranbaxy plant in the U.S. where the pills are finished.
Last month, Ranbaxy Laboratories recalled its version of the cholesterol-fighting pill Lipitor. By last week, the company had stopped making the drug, at least until it can iron out the manufacturing problems that caused fine glass particles to crop up in some pills. Along the way, the Indian company hasn't said much, at least not publicly--and that has inspired a New Jersey man to sue for information, not to mention a refund, Pharmalot reports.
Ranbaxy Laboratories' recall of generic Lipitor has spawned its first legal repercussion.
Ranbaxy Laboratories is trying to determine if a missing fragment of glass from a shield of a piece of machinery at a plant in India is the source of the problem that has caused it to halt production on its lucrative generic Lipitor product
Pfizer's U.S. sales reps are updating their résumés. The company's primary care sales force faces another round of job cuts, numbers as yet unspecified. The laid-off reps--to be notified Dec. 20, Dow Jones reports--will join thousands of previous patent-cliff casualties.
The market has been focused this week on the recall of generic Lipitor by Ranbaxy Laboratories but it turns out there was another Indian generics company that recently retrieved a key generic drug.
The potential manufacturing glitches that Ranbaxy Laboratories has been having with generic Lipitor production are more complicated than initially suggested when the Indian generics maker ordered a recall last week because some pills may contain tiny glass particles. It turns out there was an earlier recall three months ago because of possible mispackaged pills that escaped broad public notice.
The generic Lipitor that Ranbaxy Laboratories has recalled came out of an Indian plant that for the past 7 months has been under the watchful eye of a phalanx of independent consultants mandated under a 5-year consent decree made with federal authorities in the U.S.
Ranbaxy Laboratories has stumbled again, only about 7 months after its return from FDA banishment from the U.S. market. And it has tripped up on the drug that powered it to a massive first quarter in the U.S., atorvastatin, generic Lipitor, a product with which it was leading the world in production.