Federal Register / Vol. 79, No. 211 / Friday, October 31, 2014 / Notices 64807 

Dated: October 27, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25910 Filed 10–30–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1577] 

Determination That TOPICORT 

(Desoximetasone) Cream and Other 

Drug Products Were Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Amy Hopkins, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6223, 

Silver Spring, MD 20993–0002, 301– 

796–5418, Amy.Hopkins@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which 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 generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is 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). 

Under § 314.161(a) (21 CFR 

314.161(a)), the Agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) Before an ANDA that 

refers to that listed drug may be 

approved, (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved, and (3) when a person 

petitions for such a determination under 

21 CFR 10.25(a) and 10.30. Section 

314.161(d) provides that if FDA 

determines that a listed drug was 

withdrawn from sale for safety or 

effectiveness reasons, the Agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA has become aware that the drug 

products listed in the table in this 

document are no longer being marketed. 

(As requested by the applicant, FDA 

withdrew approval of NDA 020611 for 

DOVONEX (calcipotriene) Solution and 

NDA 020239 for KYTRIL (granisetron 

hydrochloride) in the Federal Register 

of July 19, 2013 (78 FR 43210)). 

Application No. Drug Applicant 

NDA 017856 .............. TOPICORT (desoximetasone) Cream; Topical 0.25% ........ Taro Pharmaceuticals North America Inc., 5 Skyline Dr., 

Hawthorne, NY 10532. 

NDA 020239 .............. KYTRIL (granisetron HCl) Injectable; Injection, Equivalent 

to (EQ) 0.1 milligram (mg) Base/milliliter (mL); EQ 1 mg 

Base/mL; EQ 3 mg Base/mL; EQ 4 mg Base/4 mL.

Hoffmann La Roche Inc., 340 Kingsland St., Nutley, NJ 

07110. 

NDA 020611 .............. DOVONEX (calcipotriene) Solution; Topical, 0.005% ......... Leo Pharma Inc., 1 Sylvan Way, Parsippany, NJ 07054. 

NDA 021275 .............. LUMIGAN (bimatoprost) Solution/Drops; Ophthalmic, 

0.03%.

Allergan Inc., 2525 Dupont Dr., Irvine, CA 92623. 

NDA 021864 .............. LYBREL (ethinyl estradiol; levonorgestrel) Tablet; Oral, 

0.02 mg/0.09 mg.

Wyeth Pharmaceuticals Inc., P.O. Box 8299, Philadelphia, 

PA 19101. 

ANDA 075222 ............ Ketorolac Tromethamine Injectable; Injection, 15 mg/mL; 

30 mg/mL.

Bedford Laboratories Inc., 300 Northfield Rd., Bedford, OH 

44146. 

ANDA 075228 ............ Ketorolac Tromethamine Injectable; Injection, 30 mg/mL ... Do. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the Agency 

will continue to list the drug products 

listed in this document in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

NDAs and ANDAs listed in this 

document are unaffected by the 

discontinued marketing of the products 

subject to those NDAs and ANDAs. 

Additional ANDAs that refer to these 

products may also be approved by the 

Agency if they comply with relevant 

legal and regulatory requirements. 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: October 27, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25911 Filed 10–30–14; 8:45 am] 

BILLING CODE 4164–01–P 


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