Determination That MEGACE (Megestrol Acetate) Tablets and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 11488-11489 [2011-4594]

Download as PDF 11488 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of NILSTAT (nystatin powder (oral, 100%)) from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events and have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness.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 NILSTAT (nystatin powder (oral, 100%)) 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 NILSTAT (nystatin powder (oral, 100%)) 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: February 24, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–4595 Filed 3–1–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0318] Determination That MEGACE (Megestrol Acetate) Tablets and Nine Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA) has determined that the 10 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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. SUMMARY: FOR FURTHER INFORMATION CONTACT: Olivia Pritzlaff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6308, 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 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 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 (the FD&C 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 withdrawn 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 reasons of safety or effectiveness, 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 applicants, FDA withdrew approval of NDA 18–101 for SYMMETREL (amantadine hydrochloride (HCl)) Tablets and ANDA 84–935 for DEXEDRINE (dextroamphetamine sulfate) Tablets in the Federal Register of July 21, 2010 (75 FR 42455).) Drug Applicant NDA 16–979 .............. NDA 17–911 .............. MEGACE (megestrol acetate) Tablets, 20 milligrams (mg) and 40 mg. CLINORIL (sulindac) Tablet, 150 mg ................................... NDA 18–101 .............. emcdonald on DSK2BSOYB1PROD with NOTICES Application No. SYMMETREL (amantadine HCl) Tablet, 100 mg ................ NDA NDA NDA NDA PROCARDIA (nifedipine) Capsule, 20 mg .......................... VEPESID (etoposide) Injection, 20 mg/milliliter (mL) .......... TAXOL (paclitaxel) Injection, 6 mg/mL ................................ CEREBYX (fosphenytoin sodium) Injection, Equivalent to (EQ) 50 mg phenytoin sodium/mL. DURICEF (cefadroxil/cefadroxil hemihydrate) Oral Suspension, EQ 250 mg base/5mL and EQ 500 mg base/5 mL. DEXTROSTAT (dextroamphetamine sulfate) Tablets, 5 mg and 10 mg. Bristol Myers Squibb, P.O. Box 4000, Princeton, NJ 08543–4000. Merck Research Laboratories, Sumneytown Pike, West Point, PA 19486. Endo Pharmaceuticals, Inc., 100 Endo Blvd., Chadds Ford, PA 19317. Pfizer Inc., 235 East 42nd St., New York, NY 10017–5755. Bristol Myers Squibb. Do. Parke Davis, 2800 Plymouth Rd., Ann Arbor, MI 48106– 1047. Warner Chilcott, Inc., 100 Enterprise Dr., Suite 280, Rockaway, NJ 07866. Shire Development, Inc., 725 Chesterbrook Blvd., Wayne, PA 19087. 18–482 18–768 20–262 20–450 .............. .............. .............. .............. NDA 50–527 .............. ANDA 84–051 ............ VerDate Mar<15>2010 16:34 Mar 01, 2011 Jkt 223001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 11489 Application No. Drug Applicant ANDA 84–935 ............ DEXEDRINE (dextroamphetamine sulfate) Tablet, 5 mg .... GlaxoSmithKline, 5 Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709–3398. 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 listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs. 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 the labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: February 24, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–4594 Filed 3–1–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. emcdonald on DSK2BSOYB1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on April 12, 2011, from 8 a.m. to 5 p.m. VerDate Mar<15>2010 16:34 Mar 01, 2011 Jkt 223001 Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘White Oak Conference Center Parking and Transportation Information for FDA Advisory Committee Meetings.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Caleb Briggs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, e-mail: caleb.briggs@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On April 12, 2011, during the morning session, the committee will discuss supplemental new drug application (sNDA) 022334/S–009, trade name AFINITOR (everolimus) tablets, application submitted by Novartis Pharmaceuticals Corp. The proposed indication (use) for this product is for the treatment of patients with advanced neuroendocrine tumors (NET) of gastrointestinal, lung, or pancreatic origin. During the afternoon session, the committee will discuss sNDA 021938/ S–013, trade name SUTENT (sunitinib malate) capsules, application submitted by C.P. Pharmaceuticals International C.V., represented by Pfizer, Inc. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of unresectable pancreatic neuroendocrine tumors (PNET). PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 29, 2011. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 21, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 22, 2011. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11488-11489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4594]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0318]


Determination That MEGACE (Megestrol Acetate) Tablets and Nine 
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 
10 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: Olivia Pritzlaff, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6308, 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 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 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 (the FD&C 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 withdrawn 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 Sec.  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 reasons 
of safety or effectiveness, 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 
applicants, FDA withdrew approval of NDA 18-101 for SYMMETREL 
(amantadine hydrochloride (HCl)) Tablets and ANDA 84-935 for DEXEDRINE 
(dextroamphetamine sulfate) Tablets in the Federal Register of July 21, 
2010 (75 FR 42455).)

------------------------------------------------------------------------
        Application No.                 Drug              Applicant
------------------------------------------------------------------------
NDA 16-979....................  MEGACE (megestrol    Bristol Myers
                                 acetate) Tablets,    Squibb, P.O. Box
                                 20 milligrams (mg)   4000, Princeton,
                                 and 40 mg.           NJ 08543-4000.
NDA 17-911....................  CLINORIL (sulindac)  Merck Research
                                 Tablet, 150 mg.      Laboratories,
                                                      Sumneytown Pike,
                                                      West Point, PA
                                                      19486.
NDA 18-101....................  SYMMETREL            Endo
                                 (amantadine HCl)     Pharmaceuticals,
                                 Tablet, 100 mg.      Inc., 100 Endo
                                                      Blvd., Chadds
                                                      Ford, PA 19317.
NDA 18-482....................  PROCARDIA            Pfizer Inc., 235
                                 (nifedipine)         East 42nd St., New
                                 Capsule, 20 mg.      York, NY 10017-
                                                      5755.
NDA 18-768....................  VEPESID (etoposide)  Bristol Myers
                                 Injection, 20 mg/    Squibb.
                                 milliliter (mL).
NDA 20-262....................  TAXOL (paclitaxel)   Do.
                                 Injection, 6 mg/mL.
NDA 20-450....................  CEREBYX              Parke Davis, 2800
                                 (fosphenytoin        Plymouth Rd., Ann
                                 sodium) Injection,   Arbor, MI 48106-
                                 Equivalent to (EQ)   1047.
                                 50 mg phenytoin
                                 sodium/mL.
NDA 50-527....................  DURICEF (cefadroxil/ Warner Chilcott,
                                 cefadroxil           Inc., 100
                                 hemihydrate) Oral    Enterprise Dr.,
                                 Suspension, EQ 250   Suite 280,
                                 mg base/5mL and EQ   Rockaway, NJ
                                 500 mg base/5 mL.    07866.
ANDA 84-051...................  DEXTROSTAT           Shire Development,
                                 (dextroamphetamine   Inc., 725
                                 sulfate) Tablets,    Chesterbrook
                                 5 mg and 10 mg.      Blvd., Wayne, PA
                                                      19087.

[[Page 11489]]

 
ANDA 84-935...................  DEXEDRINE            GlaxoSmithKline, 5
                                 (dextroamphetamine   Moore Dr., P.O.
                                 sulfate) Tablet, 5   Box 13398,
                                 mg.                  Research Triangle
                                                      Park, NC 27709-
                                                      3398.
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  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 listed in this document are 
unaffected by the discontinued marketing of the products subject to 
those NDAs. 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 the labeling for these drug 
products should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: February 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4594 Filed 3-1-11; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.