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Andrx Concerta

This article was originally published in The Tan Sheet

Executive Summary

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)...

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J&J Will Boost OTC Marketing Once Reliable Production Returns

Johnson & Johnson CEO Alex Gorsky says he expects 75% of OTC products previously recalled to be back on the market in 2013, and the firm will begin prioritizing marketing efforts once a consistent supply of products is restored. The McNeil Fort Washington facility will remain offline another year.

J&J Will Boost OTC Marketing Once Reliable Production Returns

Johnson & Johnson CEO Alex Gorsky says he expects 75% of OTC products previously recalled to be back on the market in 2013, and the firm will begin prioritizing marketing efforts once a consistent supply of products is restored. The McNeil Fort Washington facility will remain offline another year.

J&J Extends Delay In Returning Some OTCs To Market

CFO Caruso says operating under a consent decree with “a third party in the manufacturing facilities with us” makes it “very difficult for us to predict exactly when products will return.” Some products will not return to stores until 2013, significantly later than the original goal to relaunch all recalled liquid OTCs before 2012.

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