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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Notices effectiveness. The petitioner has identified no data or other information suggesting that QUELICIN
PRESERVATIVE FREE succinylcholine chloride Injection, 20 mg/mL, 50 mg/
mL, and 100 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of QUELICIN PRESERVATIVE FREE
succinylcholine chloride Injection, 20
mg/mL, 50 mg/mL, and 100 mg/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list QUELICIN
PRESERVATIVE FREE succinylcholine chloride Injection, 20 mg/mL, 50 mg/
mL, and 100 mg/mL, in the Discontinued Drug Product List section of the Orange Book. The Discontinued Drug Product List delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to QUELICIN PRESERVATIVE FREE
succinylcholine chloride Injection, 20
mg/mL, 50 mg/mL, and 100 mg/mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Dated: May 27, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202111802 Filed 6421; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES

Docket No. FDA2020P2174

Determination That ATROVENT
Ipratropium Bromide Metered Spray, 0.021 Micrograms/Spray and 0.042
Micrograms/Spray, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA or Agency has
SUMMARY:

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determined that ATROVENT
ipratropium bromide metered spray, 0.021 micrograms mcg/spray and 0.042
mcg/spray, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications ANDAs that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:

Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 209930002, 3017968363, Stacy.Kane@fda.hhs.gov.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 Pub. L. 98417
the 1984 amendments, which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the listed drug, which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application NDA.
The 1984 amendments include what is now section 505j7 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C.
355j7, which requires FDA to publish a list of all approved drugs.
FDA publishes this list as part of the Approved Drug Products With Therapeutic Equivalence Evaluations, which is known generally as the Orange Book. Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drugs NDA or ANDA
for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness 21 CFR 314.162.
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness.
This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug 314.161 21 CFR 314.161.

SUPPLEMENTARY INFORMATION:

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FDA may not approve an ANDA that does not refer to a listed drug.
ATROVENT ipratropium bromide metered spray, 0.021 mcg/spray, is the subject of NDA 020393 and ATROVENT
ipratropium bromide metered spray, 0.042 mcg/spray, is the subject of NDA
020394, both held by Boehringer Ingelheim Pharmaceuticals, Inc., and initially approved on October 20, 1995.
ATROVENT is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older.
In letters dated December 22, 2017, Boehringer Ingelheim Pharmaceuticals, Inc., requested withdrawal of NDA
020393 and NDA 020394 for ATROVENT ipratropium bromide. In the Federal Register of July 12, 2018 83
FR 32305, FDA announced that it was withdrawing approval of NDA 020393
and NDA 020394, effective August 13, 2018.
Lachman Consulting Services, Inc., submitted a citizen petition dated November 5, 2020 Docket No. FDA
2020P2174, under 21 CFR 10.30, requesting that the Agency determine whether ATROVENT ipratropium bromide metered spray, 0.021 mcg/
spray and 0.042 mcg/spray, were withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under 314.161 that ATROVENT ipratropium bromide metered spray, 0.021 mcg/
spray and 0.042 mcg/spray, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that ATROVENT
ipratropium bromide metered spray, 0.021 mcg/spray and 0.042 mcg/spray, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ATROVENT ipratropium bromide metered spray, 0.021 mcg/spray and 0.042 mcg/spray, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that these drug products were withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list ATROVENT
ipratropium bromide metered spray, 0.021 mcg/spray and 0.042 mcg/spray, in the Discontinued Drug Product List section of the Orange Book. The Discontinued Drug Product List
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