The eRulemaking Program

03/29/2024 | Press release | Distributed by Public on 03/29/2024 06:36

Withdrawal of Approval of Drug Application: SpecGX LLC et al.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0020]

SpecGX LLC, et al.; Withdrawal of Approval of 30 Abbreviated New Drug Applications

Agency

Food and Drug Administration, HHS.

Action

Notice.

Summary

The Food and Drug Administration (FDA or the Agency) is withdrawing approval of 30 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of April 29, 2024.

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, [email protected] .

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 040163 Meperidine Hydrochloride (HCl) Preservative Free Injectable, 10 milligrams (mg)/milliliters (mL) SpecGx LLC, 385 Marshall Ave., Webster Groves, MO 63119.
ANDA 040352 Meperidine HCl Tablets, 50 mg and 100 mg Do.
ANDA 040680 Oxycodone and Acetaminophen Solution, 325 mg/5 mL; 5 mg/5 mL Do.
ANDA 040773 Benzphetamine HCl Tablets, 50 mg Do.
ANDA 063002 Ancef in Plastic Container (cefazolin sodium) Injectable, Equivalent to (EQ) 10 mg base/mL and EQ 20 mg base/mL Baxter Healthcare Corp., 1 Baxter Pkwy., Deerfield, IL 60015.
ANDA 076280 Tizanidine HCl Tablets, EQ 2 mg base and EQ 4 mg base Target Health LLC, U.S. Agent for CASI Pharmaceuticals, Inc., 450 Commerce Boulevard, Carlstadt, NJ 07072.
ANDA 077021 Cilostazol Tablets, 100 mg Do.
ANDA 077310 Cilostazol Tablets, 50 mg Do.
ANDA 077517 Ondansetron HCl Tablets, EQ 4 mg base, EQ 8 mg base, and EQ 24 mg base Do.
ANDA 078319 Sumatriptan Succinate Injectable, EQ 4 mg base/0.5 mL (EQ 8 mg base/mL) and EQ 6 mg base/0.5 mL (EQ 12 mg base/mL) Antares Pharma, Inc., 100 Princeton South Corporate Center, Suite 300, Ewing, NJ 08628.
ANDA 087748 Blephamide S.O.P (Prednisolone Acetate; Sulfacetamide Sodium) Ointment, 0.2%; 10% Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612.
ANDA 087804 Butalbital, Acetaminophen, and Caffeine Tablets, 325 mg; 50 mg; 40 mg SpecGx LLC.
ANDA 087846 Imipramine HCl Tablets, 10 mg, 25 mg, and 50 mg Do.
ANDA 090623 Ranitidine HCl Syrup, EQ 15 mg base/mL Aurobindo Pharma USA, Inc., U.S. Agent for Aurobindo Pharma Ltd., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520.
ANDA 202321 Oxymorphone HCl Tablets, 5 mg, and 10 mg SpecGx LLC.
ANDA 202946 Oxymorphone HCl Extended-Release Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg Do.
ANDA 204823 Cyproheptadine HCl Syrup, 2 mg/5 mL Patrin Pharma, Inc., P.O. Box 1481, Skokie, IL 60076.
ANDA 206672 Entecavir Tablets, 0.5 mg and 1 mg Target Health LLC.
ANDA 206710 Paricalcitol Capsules, 1 microgram (mcg), 2 mcg, and 4 mcg Alvogen PB Research and Development LLC, U.S. Agent for Lotus Pharmaceutical Co., Ltd., Nantou Plant, 44 Whippany Rd, Suite 300, Morristown, NJ 07960.
ANDA 207578 Ranitidine HCl Tablets, EQ 150 mg base Aurobindo Pharma USA, Inc.
ANDA 207579 Ranitidine HCl Tablets, EQ 75 mg base Do.
ANDA 209550 Tenofovir Disoproxil Fumarate Tablets, 300 mg Target Health LLC.
ANDA 209787 Methotrexate Sodium Tablets, EQ 2.5 mg base Alvogen PB Research and Development LLC.
ANDA 210228 Ranitidine HCl Tablets, EQ 150 mg base PTS Consulting, LLC, U.S. Agent for THINQ Pharma-CRO Private Ltd., 6739 Vahalla Ct., Shawnee, KS 66217.
ANDA 210250 Ranitidine HCl Tablets, EQ 75 mg base Do.
ANDA 211058 Ranitidine HCl Capsules, EQ 150 mg base and EQ 300 mg base Aurobindo Pharma USA, Inc.
ANDA 212312 Sildenafil Citrate for Suspension, EQ 10 mg base/mL Tris Pharma, Inc., 2033 Route 130, Suite D, Monmouth Junction, NJ 08852.
ANDA 212626 Vigabatrin for Solution, 500 mg/packet SpecGx LLC.
ANDA 213456 Colesevelam HCl Tablets, 625 mg SPH Phililab Inc., 5207 Militia Hill Rd., Suite 100, Plymouth Meeting, PA 19462.
ANDA 215343 Fluticasone Propionate Ointment, 0.005% BF Suma Pharmaceuticals Inc., U.S. Agent for Bright Future Pharmaceutical Laboratories Ltd., 5001 Earle Ave., Rosemead, CA 91770.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 29, 2024. 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 listed in the table without an approved new drug application or ANDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in the table that are in inventory on April 29, 2024 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: March 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06730 Filed 3-28-24; 8:45 am]
BILLING CODE 4164-01-P