Schering NDAs Not Subject To Extra Scrutiny Under FDA Consent Decree
This article was originally published in The Tan Sheet
Executive Summary
Schering-Plough's pending supplemental NDAs to switch Claritin (loratadine) OTC appear to be unaffected by the company's GMP consent decree with FDA
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Schering GMP work plan
FDA has signed off on Schering-Plough's GMP work plan created as part of firm's 2002 consent decree. Schering noted in an 18-K filed with SEC June 3 that FDA concurred with the GMP compliance work plan May 14. The plan was submitted last year following a consent decree requiring Schering "to develop and submit for FDA's concurrence comprehensive cGMP work plans for the company's manufacturing facilities in New Jersey and Puerto Rico." Work plan details "significant steps" the firm must take to avoid fines under the consent decree. If Schering significantly misses a deadline, it may be forced to halt production of a drug. Under the decree, firm agreed to cease manufacturing of more than a dozen OTC drug SKUs (2"The Tan Sheet" May 27, 2002, p. 12). Schering also is under criminal investigation by Boston U.S. Attorney's Office for off-label promotion and other marketing practices relating to Rx drugs, firm said May 30...
Schering GMP work plan
FDA has signed off on Schering-Plough's GMP work plan created as part of firm's 2002 consent decree. Schering noted in an 18-K filed with SEC June 3 that FDA concurred with the GMP compliance work plan May 14. The plan was submitted last year following a consent decree requiring Schering "to develop and submit for FDA's concurrence comprehensive cGMP work plans for the company's manufacturing facilities in New Jersey and Puerto Rico." Work plan details "significant steps" the firm must take to avoid fines under the consent decree. If Schering significantly misses a deadline, it may be forced to halt production of a drug. Under the decree, firm agreed to cease manufacturing of more than a dozen OTC drug SKUs (2"The Tan Sheet" May 27, 2002, p. 12). Schering also is under criminal investigation by Boston U.S. Attorney's Office for off-label promotion and other marketing practices relating to Rx drugs, firm said May 30...
Schering GMP work plan
FDA has signed off on Schering-Plough's GMP work plan created as part of firm's 2002 consent decree. Schering noted in an 18-K filed with SEC June 3 that FDA concurred with the GMP compliance work plan May 14. The plan was submitted last year following a consent decree requiring Schering "to develop and submit for FDA's concurrence comprehensive cGMP work plans for the company's manufacturing facilities in New Jersey and Puerto Rico." Work plan details "significant steps" the firm must take to avoid fines under the consent decree. If Schering significantly misses a deadline, it may be forced to halt production of a drug. Under the decree, firm agreed to cease manufacturing of more than a dozen OTC drug SKUs (2"The Tan Sheet" May 27, 2002, p. 12). Schering also is under criminal investigation by Boston U.S. Attorney's Office for off-label promotion and other marketing practices relating to Rx drugs, firm said May 30...