C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG › Subpart D—FDA Action on Applications and Abbreviated Applications

21 C.F.R. § 314.162

Removal of a drug product from the list

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(a) FDA will remove a previously approved new drug product from the list for the period stated when:

(1) The agency withdraws or suspends approval of a new drug application or an abbreviated new drug application under § 314.150(a) or § 314.151 or under the imminent hazard authority of section 505(e) of the act, for the same period as the withdrawal or suspension of the application; or

(2) The agency, in accordance with the procedures in § 314.153(b) or § 314.161, issues a final decision stating that the listed drug was withdrawn from sale for safety or effectiveness reasons, or suspended under § 314.153(b), until the agency determines that the withdrawal from the market has ceased or is not for safety or effectiveness reasons.

(b) FDA will publish in the Federal Register a notice announcing the removal of a drug from the list.

(c) At the end of the period specified in paragraph (a)(1) or (a)(2) of this section, FDA will relist a drug that has been removed from the list. The agency will publish in the Federal Register a notice announcing the relisting of the drug.

[57 FR 17996, Apr. 28, 1992]
Notes of Decisions
Cited in 3 cases, 1997–2012 · leading case: Ista Pharm., Inc. v. Food & Drug Admin., 898 F. Supp. 2d 227 (D.D.C. 2012).
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Ista Pharm., Inc. v. Food & Drug Admin., 898 F. Supp. 2d 227 (D.D.C. 2012). “” 21 C.F.R. § 314.162 (a). Moreover, FDA regulations explicitly anticipate that ANDAs will rely upon drugs that the manufacturer no longer sells: An abbreviated new drug application that refers to, or a petition under section 505(j)(2)(C) of the act and § 314.”
Somerset Pharm., Inc. v. Shalala, 973 F. Supp. 443 (D. Del. 1997). “1) Somerset requested that the FDA remove the tablet form of the drug from its Approved Drug Products List pursuant to 21 C.F.R. § 314.162 . 3 In response to the FDA’s withdrawal of the drug from the approved drug list, three other drug companies, all of which had submitted…”
Ista Pharm., Inc. v. Food & Drug Admin., No. 2011-0907 (D.D.C. July 9, 2012). “” 21 C.F.R. § 314.162 (a). Moreover, FDA regulations explicitly anticipate that ANDAs will rely upon drugs that the manufacturer no longer sells: An abbreviated new drug application that refers to, or a petition under section 505(j)(2)(C) of the act and § 314.”
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