FDA issues warning about shortened cancer drug name
Whats in a name? A lot, according to a new warning from the Food and Drug Administration (FDA).
May 07, 2013 at 06:00 AM
2 minute read
The original version of this story was published on Law.com
What's in a name? A lot, according to a new warning from the Food and Drug Administration (FDA).
The agency on Monday alerted the public that using a shorter name for the new breast cancer drug Kadcyla may lead to confusion with another treatment. Kadcyla, which is manufactured by a subsidiary of the Roche group, is properly known as ado-trastuzumab emtansine. This is similar to another Roche drug, the breast cancer therapy Herceptin, which is generically known as trastuzumab.
Mix-ups between the two drugs would be problematic, the FDA said, because the medications have very different dosing and treatment schedules. To prevent this, the agency advised medical professionals to use both Kadcyla's brand name and generic name in treatment orders and medical records.
Several medication errors were reported during clinical trials for the drug; however, the FDA did note that no such confusion is known to have occurred since Kadcyla was approved on Feb. 22.
Roche told Thomson Reuters that it has designed new packaging for Kadcyla to distinguish it from Herceptin, and that it tacked had previously tacked the “ado” prefix onto the drug at the FDA's request.
For more InsideCounsel coverage of the pharmaceutical industry, see:
FDA appeals “morning after” pill ruling
IP: Obamacare's constitutional impact on patents
Generic-drug makers sue brand-name companies for product samples
2nd Circuit throws FDA's drug misbranding cases into question
This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
To view this content, please continue to their sites.
Not a Lexis Subscriber?
Subscribe Now
Not a Bloomberg Law Subscriber?
Subscribe Now
NOT FOR REPRINT
© 2025 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
You Might Like
View AllCrypto Industry Eyes Legislation to Clarify Regulatory Framework
SEC Official Hints at More Restraint With Industry Bars, Less With Wells Meetings
4 minute readTrump Fires EEOC Commissioners, Kneecapping Democrat-Controlled Civil Rights Agency
Trending Stories
- 128 Firms Supporting Retired Barnes & Thornburg Litigator in Georgia Supreme Court Malpractice Case
- 2Boosting Litigation and Employee Benefits Practices, Two Am Law 100 Firms Grow in Pittsburgh
- 3EMT Qualifies as 'Health Care Provider' Under Whistleblower Act, State Appellate Court Rules
- 4Bar Report - Feb. 3
- 5Was $1.3M in 'Incentive' Payments Commission? NJ Justices Weigh Arguments
Who Got The Work
J. Brugh Lower of Gibbons has entered an appearance for industrial equipment supplier Devco Corporation in a pending trademark infringement lawsuit. The suit, accusing the defendant of selling knock-off Graco products, was filed Dec. 18 in New Jersey District Court by Rivkin Radler on behalf of Graco Inc. and Graco Minnesota. The case, assigned to U.S. District Judge Zahid N. Quraishi, is 3:24-cv-11294, Graco Inc. et al v. Devco Corporation.
Who Got The Work
Rebecca Maller-Stein and Kent A. Yalowitz of Arnold & Porter Kaye Scholer have entered their appearances for Hanaco Venture Capital and its executives, Lior Prosor and David Frankel, in a pending securities lawsuit. The action, filed on Dec. 24 in New York Southern District Court by Zell, Aron & Co. on behalf of Goldeneye Advisors, accuses the defendants of negligently and fraudulently managing the plaintiff's $1 million investment. The case, assigned to U.S. District Judge Vernon S. Broderick, is 1:24-cv-09918, Goldeneye Advisors, LLC v. Hanaco Venture Capital, Ltd. et al.
Who Got The Work
Attorneys from A&O Shearman has stepped in as defense counsel for Toronto-Dominion Bank and other defendants in a pending securities class action. The suit, filed Dec. 11 in New York Southern District Court by Bleichmar Fonti & Auld, accuses the defendants of concealing the bank's 'pervasive' deficiencies in regards to its compliance with the Bank Secrecy Act and the quality of its anti-money laundering controls. The case, assigned to U.S. District Judge Arun Subramanian, is 1:24-cv-09445, Gonzalez v. The Toronto-Dominion Bank et al.
Who Got The Work
Crown Castle International, a Pennsylvania company providing shared communications infrastructure, has turned to Luke D. Wolf of Gordon Rees Scully Mansukhani to fend off a pending breach-of-contract lawsuit. The court action, filed Nov. 25 in Michigan Eastern District Court by Hooper Hathaway PC on behalf of The Town Residences LLC, accuses Crown Castle of failing to transfer approximately $30,000 in utility payments from T-Mobile in breach of a roof-top lease and assignment agreement. The case, assigned to U.S. District Judge Susan K. Declercq, is 2:24-cv-13131, The Town Residences LLC v. T-Mobile US, Inc. et al.
Who Got The Work
Wilfred P. Coronato and Daniel M. Schwartz of McCarter & English have stepped in as defense counsel to Electrolux Home Products Inc. in a pending product liability lawsuit. The court action, filed Nov. 26 in New York Eastern District Court by Poulos Lopiccolo PC and Nagel Rice LLP on behalf of David Stern, alleges that the defendant's refrigerators’ drawers and shelving repeatedly break and fall apart within months after purchase. The case, assigned to U.S. District Judge Joan M. Azrack, is 2:24-cv-08204, Stern v. Electrolux Home Products, Inc.
Featured Firms
Law Offices of Gary Martin Hays & Associates, P.C.
(470) 294-1674
Law Offices of Mark E. Salomone
(857) 444-6468
Smith & Hassler
(713) 739-1250