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's recent history with generic Lipitor has one drama after another. First, the company failed to win FDA approval for its version until the eleventh hour. The agency's blessing was so uncertain, the company set up a backup supply deal with Teva Pharmaceutical Industries ($TEVA). Then, Ranbaxy got its approval, and in short order captured hundreds of millions in sales. But less than a year after that launch came the recall.
As Pharmalot reports, the company says it has been in regular communication with the FDA about its generic Lipitor issues. The recall didn't extend to patients, but to pharmacies, and though FDA at first told patients to stop using their Ranbaxy pills, a few days later, the agency said the drug was OK to take.
So far, the company says it's only aware of one patient complaining of side effects, which wouldn't seem to lend the new lawsuit much weight. Still, the suit claims Ranbaxy didn't do enough to let patients know, and to instruct patients what to do about the recall, Pharmalot reports.
- read the Pharmalot piece