AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
DATES:
Approval is withdrawn as of August 27, 2021.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-402-6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.
| Application No. | Drug | Applicant |
|---|---|---|
| ANDA 040265 | Methotrexate Sodium Injection, Equivalent to (EQ) 25 milligrams (mg) base/milliliters (mL) | Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. |
| ANDA 070963 | Clonidine Hydrochloride (HCl) Tablets, 0.3 mg | Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Bldg. A, Parsippany, NJ 07054. |
| ANDA 074292 | Dobutamine HCl Injection, EQ 12.5 mg base/mL | Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. |
| ANDA 075069 | Etodolac Tablets, 400 mg | Watson Laboratories, Inc. |
| ANDA 075856 | Midazolam HCl Injection, EQ 1 mg base/mL and EQ 5 mg base/mL | Hospira, Inc. |
| ANDA 084504 | Hydralazine HCl Tablets, 25 mg | Watson Laboratories, Inc. |
| ANDA 090379 | Budesonide Delayed Release Capsules, 3 mg | Barr Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Bldg. A, Morris Corporate Center III, Parsippany, NJ 07054. |
| ANDA 091590 | Losartan Potassium Tablets, 25 mg, 50 mg, and 100 mg | Mylan Pharmaceuticals Inc., a Viatris Company, 81 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. |
| ANDA 091652 | Hydrochlorothiazide and Losartan Potassium Tablets, 12.5 mg/50 mg, 12.5 mg/100 mg, and 25 mg/100 mg | Do. |
| ANDA 204361 | Eptifibatide Injection, 2 mg/mL and 75 mg/100 mL | USV Private Limited, U.S. Agent, Omega Pharmaceutical Consulting, Inc., 752 West Shuhthagi Lane, New Harmony, UT 84757. |
| ANDA 204362 | Eptifibatide Injection, 2 mg/mL | Do. |
| ANDA 204464 | Sodium Fluoride F-18 Injection, 10-200 millicurie/mL | Decatur Memorial Hospital, 2300 North Edward St., Suite 100, Decatur, IL 62526. |
| ANDA 206177 | Docetaxel Injection, 20 mg/mL (20 mg/mL), 80 mg/4 mL (20 mg/mL), and 200 mg/10 mL (20 mg/mL) | DFB Oncology, LLC, 3909 Hulen St., Fort Worth, TX 76107. |
| ANDA 206631 | Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 mg | Lupin Limited, U.S. Agent, Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202. |
| ANDA 209399 | Olanzapine Tablets, 2.5 mg, 5 mg, and 10 mg | Jiangsu Hansoh Pharmaceutical Group Co., Ltd., U.S. Agent, eVenus Pharmaceutical Laboratories Inc., 506 Carnegie Center, Suite 100, Princeton, NJ 08540. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 27, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on August 27, 2021 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.
Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16047 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P