"The Tan Sheet" this week looks at adverse event reporting data that may point to a kidney stones risk among consumers taking GlaxoSmithKline's weight-loss drug alli (orlistat). Not exactly opportune timing for Glaxo, which is trying to unload the drug, along with other non-core OTCs.
Our Jan. 16 issue also features stories on a wrongful death lawsuit against Johnson & Johnson relating to its recalled OTC products; Novartis' recalls of Bufferin and Excedrin after quality control issues arose at one of its plants; and Perrigo's forthcoming private-label Mucinex launch.
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"The Tan Sheet," Jan. 16, 2012, Vol. 20, No. 3
Top Stories
FDA Evaluates Alli For Potential Serious Risk Of Kidney Stones: FDA adds kidney stones to the list of potential signals of a serious risk for alli based on AER information gathered between July and October 2011. GSK, which is confident in the safety and efficacy of alli when used correctly, placed the only OTC weight-loss drug on the auction block last April, but needs a buyer.
Perrigo Sets Generic Mucinex Launch After Patent Claim Decision: The private labeler clears a Reckitt Benckiser legal hurdle and will launch generic Mucinex (guaifenesin) by April. Watson has filed ANDAs for three Mucinex products and could be a good strategic partner for Perrigo, an analyst suggests.
J&J Wrongful Death Lawsuit Alleges Recalled Tylenol Link: The Tylenol product was from among the recalled lots, but remained available to “preserve the continuation of their billion dollar revenue stream,” the suit alleges. Serious adverse events did not prompt the recalls, which were announced comprehensively, the firm says.
Novartis Opts For OTC Recall, With J&J/McNeil Lessons Still Fresh: After shuttering its Lincoln, Neb., OTC facility, the firm recalls some lots of Bufferin, Excedrin, Gas-X and NoDoz. FDA found a “pattern of problems” when inspecting the plant in 2011, and Novartis’ actions suggest it seeks to avoid the same scrutiny that Johnson & Johnson’s OTC recalls elicited.
- Dan Schiff (d.schiff@elsevier.com)
