FDA Pressure Likely In Novartis OTC Plant Shutdown, Recalls
This article was originally published in The Tan Sheet
FDA inspectors were in Novartis Consumer Health’s Lincoln, Neb., plant in December and January, as the company was deciding to halt production and recall products. An inspection report notes 10 observations – eight of them repeats from FDA’s visit in mid-2011.
You may also be interested in...
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.
Perrigo Takes Two Steps Forward: Generic Allegra Launch, Manufacturing Compliance
Perrigo stokes momentum behind already healthy sales growth with significant steps in separate areas: a green light for regulatory compliance at its main manufacturing plant, and the launch of its generic OTC versions of Sanofi-Aventis' Allegra.
Firm has pending ANDAs for generic versions of McNeil's Rx Concerta (methylphenidare hydrochloride) extended-release tablets in 18, 27, 36 and 54 mg formulations. McNeil's exclusivity for the pediatric hyperactivity deficit disorder drug was set to expire March 17, and the firm has filed a citizen petition with FDA "that affects the timing of, and potentially the approval criteria for, ANDA approvals relating to generic Concerta," according to Andrx. McNeil put 300 sales reps behind the drug in 2000 (1"The Tan Sheet," April 24, 2000, In Brief)...