Azithromycin Dihydrate: Package Insert and Label Information

AZITHROMYCIN DIHYDRATE- azithromycin dihydrate tablet, coated
Lannett Company, Inc.

IMPORTANT PRESCRIBING INFORMATION

April 2020

Subject: Temporary Importation of Azithromycin Tablets to Address Drug Shortage

Dear Healthcare Professional,

Due to the current critical shortage of Azithromycin tablet products in the United States (U.S.) market, HEC Pharm USA Inc. (HEC), in conjunction with Lannett Company, Inc. (Lannett), is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of the drug. HEC has initiated temporary importation of non-FDA approved Azithromycin Film-Coated Tablets (500 mg) into the U.S. market. The Azithromycin Tablets are approved and marketed in Germany in accordance to the EU requirements. The product is manufactured in a facility approved by the FDA and packaged in an EU approved facility.

At this time, no other entity except HEC or its distributor Lannett is authorized by the FDA to import or distribute HEC’s Azithromycin Tablets in the United States. FDA has not approved HEC’s Azithromycin Tablets manufactured for the German market.

Effective immediately and during this temporary period, Lannett will distribute the presentations listed in below Table.

Product Name and Description

Size

NDC

Azithromycin Film-Coated Tablets 500 mg

3 tabs/blister,1 blister/carton

0527-2750-17

There are some key differences in the labeling between the U.S. marketed azithromycin and HEC’s imported Azithromycin Tablets. It is important to note the following:

– The imported azithromycin product labeling contains German only text used and approved for marketing in Germany. An example image of this labeling is provided below. Each bundle (10 cartons per bundle) of imported azithromycin contains an English translated package leaflet and one copy of this DHCP Letter. The following German terminology and translated meaning are present on the imported azithromycin product labeling:
— The terminology “Ch. –B.” means: Batch Number/Lot Number
— The terminology “Verw. bis” means: Expiration date
— The terminology “SN” means: Serial number which is for the EU tracking system;

Example of the carton for the Azithromycin 500mg

500mg
(click image for full-size original)

– The imported product is labeled “Azithromycin HEC 500mg Filmtabletten” which means Azithromycin HEC 500 mg Film-coated Tablets, HEC is the Marketing Authorization (MA) Holder’s name which was allowed to be added to the product name in Germany.

– The imported azithromycin product blister packaging is not child-resistant. It is important to store the product out of reach of children.

The barcode on the imported product label may not register with U.S. scanning systems. Institutions should manually input the product information into their systems to confirm that barcode systems do not provide incorrect information when the product is scanned. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.

Azithromycin Tablet is available only by prescription in the U.S. Please refer to the FDA-approved package insert for the full prescribing information of Azithromycin 500 mg tablets at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2b0c06b-e93d-f5aa-e053-2995a90ac9aa

If you have any questions about the information contained in this letter or the use of the imported products, please contact Lannett Company, Inc. at (215) 333-9000, extension 4. This DHCP letter is posted at: http://www.lannett.com.

To place an order, please contact Lannett Company, Inc. for service by calling (215) 333-9000, extension 4.

To report product quality issues or to replace missing barcode stickers, please contact Lannett Company, Inc. for Service by calling 1-844-834-0530.

To report adverse events associated with these imported products, please call Lannett Company, Inc. at 1-844-834-0530. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

We remain at your disposal to answer any questions you may have about our product; and provide more information if needed.

Sincerely,

kevin kong

Weiheng (Kevin) Kong

CEO & President

HEC Pharm USA Inc.

9000 State Road,

Philadelphia, PA, 19136, US

Phone: 267-348-3664

Email: ra_hec@hecpharm.com;

NDC 0527-2750-17 Azithromycin tablets 500 mg

500mg(1)
(click image for full-size original)
AZITHROMYCIN DIHYDRATE
azithromycin dihydrate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-2750
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
TALC
GLYCERYL MONOCAPRYLOCAPRATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)
POLYVINYL ALCOHOL (100000 MW)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code S5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-2750-17 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 3 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (0527-2750-17)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug for use in drug shortage 04/18/2020
Labeler — Lannett Company, Inc. (002277481)
Registrant — Sunshine Lake Pharma Co., Ltd. (545391443)
Establishment
Name Address ID/FEI Operations
Formula Pharmazeutische und chemische Entwicklungs GmbH 313712622 analysis (0527-2750)
Establishment
Name Address ID/FEI Operations
MARIFARM, d.o.o. 360192929 repack (0527-2750)
Establishment
Name Address ID/FEI Operations
Sunshine Lake Pharma Co., Ltd. 545391443 manufacture (0527-2750)

Revised: 04/2020 Lannett Company, Inc.

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