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Tamiflu and Relenza Emergency Use Authorization Disposition Letters and Question and Answer Attachments

 HHS LogoDEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration

Silver Spring MD 20993

 
June 22, 2010

 

Thomas R. Frieden, MD, MPH

Director

Centers for Disease Control and Prevention

1600 Clifton Rd., MS D-14

Atlanta, GA 30333

 

Re: Disposition of Certain Antiviral Drugs—Zanamivir and Oseltamivir Phosphate

 

Dear Dr. Frieden:

 

This letter responds to your request regarding the disposition of certain zanamivir and oseltamivir phosphate drugs upon termination of the authorization of emergency use that was issued on April 27, 2009, pursuant to section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360bbb-3.

 

Attachment 1 provides Questions and Answers Regarding Terminating Certain Emergency Uses of Tamiflu and Relenza.

 

Attachment 2 provides Update Regarding Stockpiled Antivirals at or Nearing Expiration.

 

Sincerely,
 
_____________________________
Margaret Hamburg, M.D.
Commissioner of Food and Drugs

 

 


 

 

ATTACHMENT 1:

Questions and Answers Regarding Termination of the Emergency Use Authorizations (EUAs) for Tamiflu (oseltamivir) and Relenza (zanamivir)

 

During the 2009 H1N1 influenza public health emergency, FDA issued Emergency Use Authorizations (EUAs) that authorized certain unapproved uses of Tamiflu and Relenza.

 

On June 21, 2010, the U.S. Food and Drug Administration (FDA) notified the Centers for Disease Control and Prevention (CDC) that these EUAs will terminate when the Public Health Emergency determination for 2009 H1N1 Influenza expires on June 23, 2010. Therefore, after June 23, 2010, the EUAs authorizing the unapproved uses of Tamiflu and Relenza will no longer be in effect.

 

Q1. What is an EUA?

A. An EUA may be issued by FDA to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.

 

Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act), amended by the Project BioShield Act of 2004, permits authorization of such products for use in diagnosing, treating, or preventing serious or life-threatening diseases or conditions caused by biological, chemical, radiological, or nuclear agents, if certain statutory criteria are met.

 

Q2. What unapproved uses for Tamiflu and Relenza were authorized under the 2009 H1N1 influenza public health emergency EUAs?

A. Under the EUA, Tamiflu was authorized:

  • To treat and prevent influenza in children under 1 year of age. Due to limited experience in infants less than 3 months of age, use of Tamiflu for prevention of 2009 H1N1 flu in this age group was not routinely recommended, but Tamiflu could have been used if the need was considered critical, e.g., if exposure was significant, if risk of severe illness was considered high.
  • With dosing recommendations for children under the age of 1 year

Under the EUAs, Tamiflu and Relenza were authorized:

  • For use at later time points after onset of symptoms. For example, for use in patients who were symptomatic for more than 2 days or in patients sick enough to require hospitalization ( i.e., patients with complicated influenza)
  • To be distributed or dispensed by public health authorities without all of the FDA-required prescription label information
  • To be accompanied by certain written emergency use information (Fact Sheets)
  • To be distributed by public health officials or other volunteers to recipients in accordance with applicable state and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction
  • For certain lots of Tamiflu for Oral Suspension, Tamiflu Capsules, and Relenza Inhalation Powder, for use beyond their labeled expiration dates

Q3. After the termination of the EUAs, what are FDA's recommendations regarding the previously-authorized, unapproved uses of Tamiflu and Relenza?

 

A. After June 23, 2010, Tamiflu and Relenza should be distributed and dispensed in compliance with FDA regulations and State laws, and in accordance with FDA-approved product labeling.

 

Tamiflu is approved by the FDA for the following indications:

  • Treatment of uncomplicated acute illness due to influenza A and B virus infection in patients 1 year and older who have been symptomatic for no more than two days.
  • Prophylaxis (prevention) of influenza A and B virus in patients 1 year and older.

Relenza is approved by the FDA for the following indications:

  • Treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who have been symptomatic for no more than two days.
  • Prophylaxis (prevention) of influenza A and B virus in adults and pediatric patients 5 years of age and older.

Q4. The EUA for Tamiflu provided dosing recommendations for Tamiflu in children less than 1 year of age. Has this dosing regimen been approved by FDA?

 

A. No. Tamiflu is approved for patients 1 year and older, and FDA has not approved dosing for children less than 1 year of age.

 

 


 

 

ATTACHMENT 2

Update Regarding Stockpiled Antivirals at or Nearing Expiration

During the 2009 H1N1 influenza public health emergency, the FDA issued Emergency Use Authorizations (EUAs) authorizing the emergency use of certain expired lots of Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) based on scientific review and analysis that found the drugs could be used beyond their labeled expiration dates.

On June 21, 2010, the U.S. Food and Drug Administration (FDA) notified the Centers for Disease Control and Prevention (CDC) that these EUAs for Tamiflu and Relenza will terminate when the Public Health Emergency determination for 2009 H1N1 Influenza expires on June 23, 2010. Therefore, after June 23, 2010, the emergency use of certain expired lots of Tamiflu and Relenza will no longer be authorized under the EUAs.

This statement provides CDC updated information regarding these identified lots for purposes of informing public health authorities. This statement is not directed to individual patients who already have Tamiflu and/or Relenza in their homes. If they have Tamiflu or Relenza in their homes with expired date, they should discard the product.

For additional information, contact FDA's Division of Drug Information at 1-888-463-6332

Storage of Tamiflu and Relenza

If Tamiflu and/or Relenza is retained, it must be maintained and monitored under the product's labeled storage conditions. Tamiflu and Relenza should be stored at controlled room temperature.The United States Pharmacopeia (USP) defines controlled room temperature as a temperature that is maintained by thermostat and is between 20 and 25˚C (68 to 77˚ F).

Disposition of Identified Lots of Tamiflu and Relenza

Tamiflu Capsules and Relenza Inhalation Powder

FDA approved supplemental New Drug Applications for Relenza Inhalation Powder and Tamiflu Capsules that provided an expiration dating period of seven years. Approvals of new drug applications are generally prospective. FDA is aware that the following lots of Relenza Inhalation Powder and Tamiflu Capsules are currently packaged with an expiration date less than seven years. Provided that the products have been stored under the labeled storage conditions, FDA believes it would be scientifically supportable for the expiry extension (for a maximum of seven years) to apply to these lots that have already been manufactured. Thus FDA does not intend to take an enforcement action with regard to the following lots of Relenza Inhalation Powder and Tamiflu Capsules that are retained for potential use in future emergencies, provided that the products have been stored under the labeled storage conditions.

 

To minimize confusion on the part of healthcare professionals and patients, FDA recommends, prior to dispensing, that the identified lots be relabeled/repackaged by an FDA registered firm in accordance with applicable Current Good Manufacturing Practice (CGMP) requirements under 21 CFR 210, 211. (A relabeling/repackager firm's registration status can be confirmed/verified at the following website: http://www.fda.gov/Drugs/InformationOnDrugs/ucm135778.htm).

 

For Tamiflu Capsule blister packages and Relenza Diskhalers:

 

The registered relabeler/repackager should place the product in a sleeve and include the following printed statement with the product:

 

"FDA has determined that it is scientifically supportable to use this product beyond the printed expiration date that is on original label and internal components until [Enter 7 Year Expiry Date from Tables below]"

 

Tamiflu Capsules 75mg Blister Package

 

Lot Number Unit
(10 capsules per
blister package)
Manufacturer's original expiry date 7 Year Expiry Date
B1060 Blister package November 30, 2007 November 03, 2010
B1061-01 Blister package November 30, 2007 November 04, 2010
B1061-02 Blister package November 30, 2007 November 04, 2010
B1062 Blister package December 31, 2007 December 08, 2010
B1063 Blister package December 31, 2008 December 11, 2010
B1079 Blister package October 31, 2009 October 31, 2011
B1080 Blister package October 31, 2009 October 31, 2011
B1081 Blister package October 31, 2009 October 31, 2011
B1082 Blister package October 31, 2009 October 31, 2011
B1082-01 Blister package October 31, 2009 October 31, 2011
B1082-02 Blister package October 31, 2009 October 18, 2011
B1086 Blister package November 30, 2009 November 30, 2011
B1093 Blister package November 30, 2009 November 26, 2011
B1094 Blister package November 30, 2009 November 29, 2011

 

 

Relenza Inhalation Powder Diskhaler

 

Lot Number Manufacturer's original expiry date 7 Year Expiry Date
153 November 30, 2009 November 30, 2011
154 November 30, 2009 November 30, 2011
154A November 30, 2009 November 30, 2011
237 July 31, 2011 July 31, 2013
238 July 31, 2011 July 31, 2013
270 September 30, 2011 September 30, 2013
271 September 30, 2011 September 30, 2013
273 September 30, 2011 September 30, 2013
274 September 30, 2011 September 30, 2013
275 September 30, 2011 September 30, 2013
276 September 30, 2011 September 30, 2013
277 September 30, 2011 September 30, 2013
279 September 30, 2011 September 30, 2013
280 September 30, 2011 September 30, 2013
281 September 30, 2011 September 30, 2013
282 September 30, 2011 September 30, 2013
287 September 30, 2011 September 30, 2013
292 October 31, 2011 October 31, 2013
293 October 31, 2011 October 31, 2013
294 October 31, 2011 October 31, 2013
305 October 31, 2011 October 31, 2013
306 October 31, 2011 October 31, 2013
307 October 31, 2011 October 31, 2013
308 October 31, 2011 October 31, 2013
374 January 31, 2012 January 31, 2014
518 August 31, 2012 August 31, 2014
519 August 31, 2012 August 31, 2014
521 September 30, 2012 September 30, 2014
522 October 31, 2012 October 31, 2014
523 October 31, 2012 October 31, 2014
524 October 31, 2012 October 31, 2014
525 October 31, 2012 October 31, 2014
526 October 31, 2012 October 31, 2014
7ZP0106 November 30, 2012 November 30, 2014
7ZP0862 November 30, 2012 November 30, 2014
7ZP1431 November 30, 2012 November 30, 2014
7ZP3799 July 31, 2012 July 31, 2014
7ZP3990 August 31, 2012 August 31, 2014
7ZP4325 August 31, 2012 August 31, 2014
7ZP5504 August 31, 2012 August 31, 2014
7ZP7104 May 31, 2012 May 31, 2014
7ZP8530 October 31, 2012 October 31, 2014
7ZP8753 October 31, 2012 October 31, 2014
7ZP8870 October 31, 2012 October 31, 2014
8ZP3152 December 31, 2012 December 31, 2014

 

Tamiflu Capsules bottles:

 

The registered relabeler/repackager should place a sticker over the old expiry date that does not obstruct any of the other label information with the appropriate 7 Year Expiry Date from the table below and the following statement:

 

"FDA has determined that it is scientifically supportable to use this product until [Enter 7 Year Expiry Date from Tables below]"

 

Tamiflu Capsule 75 mg Bottles

 

Lot Number Unit
(10 capsules per
bottle)
Manufacturer's original expiry date 7 Year Expiry Date
B1090 Bottles November 30, 2009 November 30, 2011
B1100 Bottles December 31, 2009 December 31, 2011
B1100-01 Bottles December 31, 2009 December 31, 2011
B1109 Bottles January 31, 2010 January 31, 2012
B1118  Bottles April 30, 2010 April 30, 2012
B1122 Bottles May 31, 2010 May 31, 2012
B1148 Bottles July 31, 2010 July 31, 2012
B1149 Bottles July 31, 2010 July 31, 2012
U2011 Bottles September 30, 2010 September 30, 2012
U2012 Bottles September 30, 2010 September 30, 2012
U2013 Bottles September 30, 2010 September 30, 2012
U2017 Bottles January 31, 2011 January 31, 2013
U2021 Bottles March 31, 2011 March 31, 2013
U2051 Bottles August 31, 2011 August 31, 2013
U400050 Bottles May 31, 2011 May 31, 2013
U400150 Bottles May 31, 2011 May 31, 2013
U400250 Bottles   May 31, 2011 May 31, 2013
U4008-10 Bottles August 31, 2011 August 31, 2013
U4030-02 Bottles October 31, 2011 October 31, 2013
U4031-01 Bottles October 31, 2011 October 31, 2013
U4032-01 Bottles October 31, 2011 October 31, 2013
U4033-01 Bottles October 31, 2011 October 31, 2013
U4034-01 Bottles October 31, 2011 October 31, 2013
U4037-01 Bottles October 31, 2011 October 31, 2013

 

The following lots of Tamiflu Capsules already have an expiration dating period of 7 years. Therefore these lots can be retained only until their manufacturer's original expiry date on the label.

 

Tamiflu 30 mg Capsules

 

Lot Number Unit
(10 caps per bottle)
Manufacturer's original expiry date
B1003-50  Bottles November 30, 2014
B1004-50  Bottles November 30, 2014
B1005  Bottles November 30, 2014

 

Tamiflu 45 mg Capsules

 

Lot Number Unit
(10 caps per bottle)
Manufacturer's original expiry date
B1003-50  Bottles November 30, 2014
B1004   Bottles November 30, 2014

 

Tamiflu 75 mg Capsules

 

Lot Number Unit
(10 caps per bottle)
Manufacturer's original expiry date
U4067 Bottles August 31, 2014
U4069 Bottles September 30, 2014
U4070 Bottles September 30, 2014
U4075 Bottles November 30, 2014
U4078 Bottles November 30, 2014


Tamiflu for Oral Suspension

Unlike Tamiflu Capsules and Relenza Inhalation Powder, FDA has not approved an expiration dating period of seven years for Tamiflu for Oral Suspension. Therefore, the following lots of Tamiflu for Oral Suspension that were authorized for use under the EUA should be destroyed utilizing the facilities' pharmaceutical disposal procedures and in compliance with all applicable laws.

 


Lot Number
Manufacturer's original expiry date
B1042 January 31, 2005
B1045 May 31, 2005
B1046 November 30, 2005
B1047 November 30, 2005
B1048 January 31, 2006
B1050 January 31, 2006
B1051 January 31, 2006
B1052 January 31, 2006
B1053 January 31, 2006
B1054 January 31, 2006
B1055 January 31, 2006
B1065 June 30, 2006
B1082 May 31, 2007
B1184 June 30, 2009
B1185 June 30, 2009
B1186 June 30, 2009
B1187 June 30, 2009
B1188 June 30, 2009
B1189 June 30, 2009
B1097 June 30, 2007
B1098 June 30, 2007
B1213 November 1, 2009
B1214 November 1, 2009
B1216 November 1, 2009
B120553 August 8, 2009
B120650 August 8, 2009