Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 250 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness, 41412-41413 [2012-17091]

Download as PDF srobinson on DSK4SPTVN1PROD with NOTICES 41412 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices drug product is equivalent to withdrawing the drug from sale. Lachman Consultant Services, Inc., submitted a citizen petition dated March 14, 2012 (Docket No. FDA–2012– P–0271), under 21 CFR 10.30, requesting that the Agency determine whether TOPOTECAN INJECTION (topotecan hydrochloride) 1 mg (base)/ 1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records, and based on the information we have at this time, FDA has determined under § 314.161 that TOPOTECAN INJECTION (topotecan hydrochloride) 1 mg (base)/ 1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that TOPOTECAN INJECTION (topotecan hydrochloride) 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of TOPOTECAN INJECTION (topotecan hydrochloride) 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list TOPOTECAN INJECTION (topotecan hydrochloride) 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to TOPOTECAN INJECTION (topotecan hydrochloride) 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: July 10, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–17090 Filed 7–12–12; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–P–0081] Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 250 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that CHLOROMYCETIN (chloramphenicol) Capsules, 250 milligrams (mg), were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for chloramphenicol capsules, 250 mg. FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6312, Silver Spring, MD 20993–0002, 301– 796–3601. 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 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 only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. 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 known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are 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 SUMMARY: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, are the subject of ANDA 60–591, held by Parkedale Pharmaceuticals, and initially approved on December 8, 1950. CHLOROMYCETIN is an antibiotic indicated to treat only serious infections for which less potentially dangerous drugs are ineffective or contraindicated. In a letter dated October 9, 2007, Parkedale Pharmaceuticals requested withdrawal of ANDA 60–591 for CHLOROMYCETIN (chloramphenicol) Capsules, 50 mg, 100 mg and 250 mg. In the Federal Register of February 11, 2009 (74 FR 6896), FDA announced that it was withdrawing approval of ANDA 60–591, effective March 13, 2009, and moved the drug to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Armenpharm, Ltd., submitted a citizen petition dated February 7, 2011 (Docket No. FDA–2011–P–0081), under 21 CFR 10.30, requesting that the Agency determine whether CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition, and based on the information we have at this time, FDA has determined under § 314.161 that CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed Agency records concerning the withdrawal of CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. At the time of the approval of CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, there was significant unmet medical need. With the approval of additional therapies with less severe adverse drug effects, FDA has determined that the risks associated with CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, as currently labeled, outweigh the benefits. Most importantly, CHLOROMYCETIN E:\FR\FM\13JYN1.SGM 13JYN1 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices (chloramphenicol) Capsules, 250 mg, may cause a number of adverse reactions, the most serious being bone marrow depression (anemia, thrombocytopenia, and granulocytopenia temporally associated with treatment). A boxed warning in the prescribing information for both chloramphenicol sodium succinate injection and chloramphenicol capsules states that serious hypoplastic anemia, thrombocytopenia, and granulocytopenia are known to occur after administration of chloramphenicol. The drug product labeling recommends extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days during therapy. The boxed warning also describes fatal aplastic anemia associated with administration of the drug and aplastic anemia attributed to chloramphenicol that later terminated in leukemia. There is published literature which suggests that the risk of fatal aplastic anemia associated with the oral formulation of chloramphenicol may be higher than the risk associated with the intravenous formation. FDA has also reviewed the latest approved labeling for the product and has determined that this labeling is inadequate and a Risk Evaluation and Mitigation Strategy (REMS) would be required to ensure that the benefits of the drug outweigh its risks. The REMS may include Elements to Assure Safe Use, including restricted distribution, and a Medication Guide could be required as part of the labeling. FDA has determined that additional nonclinical and possibly clinical studies of safety and efficacy would be necessary before CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, could be considered for reintroduction to the market. Accordingly, the Agency will remove CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to this drug product. srobinson on DSK4SPTVN1PROD with NOTICES Dated: July 10, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–17091 Filed 7–12–12; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0530] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Medical Devices: The PreSubmission Program and Meetings with FDA Staff.’’ The purpose of this guidance is to describe the PreSubmission program (formerly the preInvestigational Device Exemption (IDE) program) for medical devices reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). In addition, the guidance provides recommendations regarding information that should be included in a Pre-Submission Package. This guidance also describes the procedures that CDRH and CBER intend to follow when industry representatives or application sponsors request a meeting with review staff. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 11, 2012. Submit either written or electronic comments on this collection of information by September 11, 2012. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Medical Devices: The Pre-Submission Program and Meetings with FDA Staff’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993– 0002; or Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. SUMMARY: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 41413 Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993–0002, 301– 796–6380; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background Since its establishment in 1995, the pre-IDE program has been a successful resource for both medical device applicants and the FDA. Originally, this program was designed to provide applicants a mechanism to obtain FDA feedback on future IDE applications prior to their submission. Over time, the pre-IDE program evolved to include feedback on other device submission program areas, such as Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, and Premarket Notification (510(k)) Submissions, as well as to address questions related to whether a clinical study requires submission of an IDE. The purpose of this guidance is to update the pre-IDE program to reflect this broader scope and make important modifications to reflect changes in the premarket program areas as a result of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110–85). This guidance also broadens the scope of the program to include those devices regulated by CBER. Accordingly, FDA is changing the name for this program from the preIDE program to the Pre-Submission (PreSub) program. The main purpose of the Pre-Sub program remains the same as the preIDE program: to facilitate providing advice to applicants when they have specific questions during product development and early protocol E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41412-41413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17091]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0081]


Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 250 
Milligrams, Were 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 
CHLOROMYCETIN (chloramphenicol) Capsules, 250 milligrams (mg), were 
withdrawn from sale for reasons of safety or effectiveness. The Agency 
will not accept or approve abbreviated new drug applications (ANDAs) 
for chloramphenicol capsules, 250 mg.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-3601.

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 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 only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    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 known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, are the subject 
of ANDA 60-591, held by Parkedale Pharmaceuticals, and initially 
approved on December 8, 1950. CHLOROMYCETIN is an antibiotic indicated 
to treat only serious infections for which less potentially dangerous 
drugs are ineffective or contraindicated.
    In a letter dated October 9, 2007, Parkedale Pharmaceuticals 
requested withdrawal of ANDA 60-591 for CHLOROMYCETIN (chloramphenicol) 
Capsules, 50 mg, 100 mg and 250 mg. In the Federal Register of February 
11, 2009 (74 FR 6896), FDA announced that it was withdrawing approval 
of ANDA 60-591, effective March 13, 2009, and moved the drug to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Armenpharm, Ltd., submitted a citizen petition dated February 7, 
2011 (Docket No. FDA-2011-P-0081), under 21 CFR 10.30, requesting that 
the Agency determine whether CHLOROMYCETIN (chloramphenicol) Capsules, 
250 mg, were withdrawn from sale for reasons of safety or 
effectiveness.
    After considering the citizen petition, and based on the 
information we have at this time, FDA has determined under Sec.  
314.161 that CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, were 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed Agency records concerning the withdrawal of CHLOROMYCETIN 
(chloramphenicol) Capsules, 250 mg, from sale. We have also 
independently evaluated relevant literature and data for possible 
postmarketing adverse events. At the time of the approval of 
CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, there was significant 
unmet medical need. With the approval of additional therapies with less 
severe adverse drug effects, FDA has determined that the risks 
associated with CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, as 
currently labeled, outweigh the benefits. Most importantly, 
CHLOROMYCETIN

[[Page 41413]]

(chloramphenicol) Capsules, 250 mg, may cause a number of adverse 
reactions, the most serious being bone marrow depression (anemia, 
thrombocytopenia, and granulocytopenia temporally associated with 
treatment). A boxed warning in the prescribing information for both 
chloramphenicol sodium succinate injection and chloramphenicol capsules 
states that serious hypoplastic anemia, thrombocytopenia, and 
granulocytopenia are known to occur after administration of 
chloramphenicol. The drug product labeling recommends extensive safety 
monitoring, including baseline blood studies followed by periodic blood 
studies approximately every 2 days during therapy. The boxed warning 
also describes fatal aplastic anemia associated with administration of 
the drug and aplastic anemia attributed to chloramphenicol that later 
terminated in leukemia. There is published literature which suggests 
that the risk of fatal aplastic anemia associated with the oral 
formulation of chloramphenicol may be higher than the risk associated 
with the intravenous formation.
    FDA has also reviewed the latest approved labeling for the product 
and has determined that this labeling is inadequate and a Risk 
Evaluation and Mitigation Strategy (REMS) would be required to ensure 
that the benefits of the drug outweigh its risks. The REMS may include 
Elements to Assure Safe Use, including restricted distribution, and a 
Medication Guide could be required as part of the labeling. FDA has 
determined that additional nonclinical and possibly clinical studies of 
safety and efficacy would be necessary before CHLOROMYCETIN 
(chloramphenicol) Capsules, 250 mg, could be considered for 
reintroduction to the market.
    Accordingly, the Agency will remove CHLOROMYCETIN (chloramphenicol) 
Capsules, 250 mg, from the list of drug products published in the 
Orange Book. FDA will not accept or approve ANDAs that refer to this 
drug product.

    Dated: July 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17091 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P

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