[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]]
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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.
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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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of April 29, 2024.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.
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Application No. Drug Applicant
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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.
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[[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