2023-11162. Determination That Chirocaine (Levobupivacaine) Injection, 2.5 Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter Vials, 5 Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter Vials and 7.5 Milligrams (Base)/...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) has determined that Chirocaine (levobupivacaine) injection, 2.5 milligrams (mg) (base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for levobupivacaine injection, 2.5 milligrams (mg) (base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:

Donna Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993–0002, 301–796–3600, [e-mail].

SUPPLEMENTARY INFORMATION:

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

Section 505(j)(7) of the FD&C Act 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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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)). FDA may not approve an ANDA that does not refer to a listed drug.

Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, is the subject of NDA 020997, held by Purdue Pharma L.P., and initially approved on August 5, 1999. Chirocaine is indicated to produce local or regional anesthesia for surgery and obstetrics, and for post-operative pain management.

In a letter dated May 21, 2004, Purdue Pharma L.P. requested withdrawal of NDA 020997 for Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials. In the Federal Register of March 4, 2005 (70 FR 10651), FDA announced that it was withdrawing approval of NDA 020997, effective April 4, 2005. Chirocaine is currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Lachman Consultant Services, Inc. submitted a citizen petition dated December 21, 2022 (Docket No. FDA–2022–P–3293), under 21 CFR 10.30, requesting that the Agency determine whether Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were withdrawn from sale for reasons of safety or efficacy.

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 Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were withdrawn for reasons of safety or effectiveness.

We have carefully reviewed our files for records concerning the withdrawal of Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, 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 Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, 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 Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials or 7.5 mg (base)/mL, 10 mL and 30 mL vials, 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 these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

Dated: May 22, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.