[Federal Register Volume 89, Number 62 (Friday, March 29, 2024)]
[Notices]
[Pages 22155-22156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06730]



[[Page 22155]]

-----------------------------------------------------------------------

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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of April 29, 2024.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 Sec.  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 Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
      Application No.                 Drug                 Applicant
------------------------------------------------------------------------
ANDA 040163...............  Meperidine Hydrochloride  SpecGx LLC, 385
                             (HCl) Preservative Free   Marshall Ave.,
                             Injectable, 10            Webster Groves,
                             milligrams (mg)/          MO 63119.
                             milliliters (mL).
ANDA 040352...............  Meperidine HCl Tablets,   Do.
                             50 mg and 100 mg.
ANDA 040680...............  Oxycodone and             Do.
                             Acetaminophen Solution,
                             325 mg/5 mL; 5 mg/5 mL.
ANDA 040773...............  Benzphetamine HCl         Do.
                             Tablets, 50 mg.
ANDA 063002...............  Ancef in Plastic          Baxter Healthcare
                             Container (cefazolin      Corp., 1 Baxter
                             sodium) Injectable,       Pkwy., Deerfield,
                             Equivalent to (EQ) 10     IL 60015.
                             mg base/mL and EQ 20 mg
                             base/mL.
ANDA 076280...............  Tizanidine HCl Tablets,   Target Health LLC,
                             EQ 2 mg base and EQ 4     U.S. Agent for
                             mg base.                  CASI
                                                       Pharmaceuticals,
                                                       Inc., 450
                                                       Commerce
                                                       Boulevard,
                                                       Carlstadt, NJ
                                                       07072.
ANDA 077021...............  Cilostazol Tablets, 100   Do.
                             mg.
ANDA 077310...............  Cilostazol Tablets, 50    Do.
                             mg.
ANDA 077517...............  Ondansetron HCl Tablets,  Do.
                             EQ 4 mg base, EQ 8 mg
                             base, and EQ 24 mg base.
ANDA 078319...............  Sumatriptan Succinate     Antares Pharma,
                             Injectable, EQ 4 mg       Inc., 100
                             base/0.5 mL (EQ 8 mg      Princeton South
                             base/mL) and EQ 6 mg      Corporate Center,
                             base/0.5 mL (EQ 12 mg     Suite 300, Ewing,
                             base/mL).                 NJ 08628.
ANDA 087748...............  Blephamide S.O.P          Allergan Sales,
                             (Prednisolone Acetate;    LLC, 2525 Dupont
                             Sulfacetamide Sodium)     Dr., Irvine, CA
                             Ointment, 0.2%; 10%.      92612.
ANDA 087804...............  Butalbital,               SpecGx LLC.
                             Acetaminophen, and
                             Caffeine Tablets, 325
                             mg; 50 mg; 40 mg.
ANDA 087846...............  Imipramine HCl Tablets,   Do.
                             10 mg, 25 mg, and 50 mg.
ANDA 090623...............  Ranitidine HCl Syrup, EQ  Aurobindo Pharma
                             15 mg base/mL.            USA, Inc., U.S.
                                                       Agent for
                                                       Aurobindo Pharma
                                                       Ltd., 279
                                                       Princeton-
                                                       Hightstown Rd.,
                                                       East Windsor, NJ
                                                       08520.
ANDA 202321...............  Oxymorphone HCl Tablets,  SpecGx LLC.
                             5 mg, and 10 mg.
ANDA 202946...............  Oxymorphone HCl Extended- Do.
                             Release Tablets, 5 mg,
                             7.5 mg, 10 mg, 15 mg,
                             20 mg, 30 mg, and 40 mg.
ANDA 204823...............  Cyproheptadine HCl        Patrin Pharma,
                             Syrup, 2 mg/5 mL.         Inc., P.O. Box
                                                       1481, Skokie, IL
                                                       60076.
ANDA 206672...............  Entecavir Tablets, 0.5    Target Health LLC.
                             mg and 1 mg.
ANDA 206710...............  Paricalcitol Capsules, 1  Alvogen PB
                             microgram (mcg), 2 mcg,   Research and
                             and 4 mcg.                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,   Aurobindo Pharma
                             EQ 150 mg base.           USA, Inc.
ANDA 207579...............  Ranitidine HCl Tablets,   Do.
                             EQ 75 mg base.
ANDA 209550...............  Tenofovir Disoproxil      Target Health LLC.
                             Fumarate Tablets, 300
                             mg.
ANDA 209787...............  Methotrexate Sodium       Alvogen PB
                             Tablets, EQ 2.5 mg base.  Research and
                                                       Development LLC.
ANDA 210228...............  Ranitidine HCl Tablets,   PTS Consulting,
                             EQ 150 mg base.           LLC, U.S. Agent
                                                       for THINQ Pharma-
                                                       CRO Private Ltd.,
                                                       6739 Vahalla Ct.,
                                                       Shawnee, KS
                                                       66217.
ANDA 210250...............  Ranitidine HCl Tablets,   Do.
                             EQ 75 mg base.
ANDA 211058...............  Ranitidine HCl Capsules,  Aurobindo Pharma
                             EQ 150 mg base and EQ     USA, Inc.
                             300 mg base.
ANDA 212312...............  Sildenafil Citrate for    Tris Pharma, Inc.,
                             Suspension, EQ 10 mg      2033 Route 130,
                             base/mL.                  Suite D, Monmouth
                                                       Junction, NJ
                                                       08852.
ANDA 212626...............  Vigabatrin for Solution,  SpecGx LLC.
                             500 mg/packet.
ANDA 213456...............  Colesevelam HCl Tablets,  SPH Phililab Inc.,
                             625 mg.                   5207 Militia Hill
                                                       Rd., Suite 100,
                                                       Plymouth Meeting,
                                                       PA 19462.
ANDA 215343...............  Fluticasone Propionate    BF Suma
                             Ointment, 0.005%.         Pharmaceuticals
                                                       Inc., U.S. Agent
                                                       for Bright Future
                                                       Pharmaceutical
                                                       Laboratories
                                                       Ltd., 5001 Earle
                                                       Ave., Rosemead,
                                                       CA 91770.
------------------------------------------------------------------------


[[Page 22156]]

    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