[Federal Register Volume 62, Number 221 (Monday, November 17, 1997)]
[Notices]
[Pages 61338-61339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket Nos. 97N-0263 and 87N-0262]


European Research Associates, Ltd. et al.; Withdrawal of Approval 
of Three New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three new drug applications (NDA's). The basis for the withdrawals 
is that the holders of the applications have repeatedly failed to file 
required annual reports on these NDA's.

EFFECTIVE DATE:  November 17, 1997.

FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: The holders of approved applications to 
market new drugs or antibiotics for human use are required to submit 
annual reports to FDA concerning each of their approved applications in 
accordance with Sec. 314.81 (21 CFR 314.81).
    In the Federal Register of July 10, 1997 (62 FR 37063), FDA offered 
an opportunity for a hearing on a proposal to withdraw approval of four 
NDA's because the firms had failed to submit the required annual 
reports for these NDA's.
    The agency received one request for a hearing from Global 
Pharmaceutical Corp., Castor and Kensington Aves., Philadelphia, PA 
19124-5694. Global has filed an annual report for NDA 9-273, Rauwolfia 
Serpentina Tablets, 50 and 100 milligram (mg). Therefore, approval of 
this NDA is not being withdrawn.
    The holders of the other three applications did not respond to the 
notice of opportunity for hearing. Failure to file a written notice of 
participation and request for a hearing as required by 21 CFR 314.200 
constitutes an election by the applicant not to make use of the 
opportunity for a hearing concerning the proposal to withdraw approval 
of the applications and a waiver of any contentions concerning the 
legal status of the drug products. Therefore, the Director, Center for 
Drug Evaluation and Research, is withdrawing approval of the NDA's 
listed in the table in this document.

                                                                                                                
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 Application No.                        Drug                                         Applicant                  
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NDA 11-623         Mucilose Super Powder                           European Research Associates, Ltd.,          
                                                                    Pailinakis Bldg., Elisabeth Ave., P.O. Box  
                                                                    N3334, Nassau, N.P., Bahamas.               
NDA 12-748         Duotrate (pentaerythritol tetranitrate)         Jones Medical Industries, Inc., 1945 Craig   
                    Capsules, 45 mg                                 Rd., St. Louis, MO 63146.                   
NDA 16-470         Duotrate (pentaerythritol tetranitrate)         Do.                                          
                    Capsules, 30 mg                                                                             
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    The last two products listed, NDA's 12-748 and 16-470, were named 
in a notice of opportunity for hearing published in the Federal 
Register of October 14, 1984 (49 FR 40213), proposing to withdraw the 
applications, along with other applicants' products, because they lack 
substantial evidence of effectiveness. In response to that notice, 
hearings were requested and a hearing was granted (52 FR 32170; August 
26, 1987); Jones Medical, the

[[Page 61339]]

successor in interest to NDA's 12-748 and 16-470, filed a Notice of 
Participation; on May 10, 1989, the Administrative Law Judge issued his 
Initial Decision, ordering that NDA's 12-748 and 16-470, and others, be 
withdrawn; Jones Medical, as well as two other parties, appealed that 
decision to the Commissioner. On the basis of the present withdrawal of 
approval of NDA's 12-748 and 16-470 for failing to file required annual 
reports, the appeal by Jones Medical in Docket No. 87N-0262 is regarded 
as withdrawn.
    The Director, Center for Drug Evaluation and Research, under 
section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(e)), and under authority of 21 CFR 5.82, finds that the holders of 
the applications listed above have repeatedly failed to submit reports 
required by Sec. 314.81. Therefore, under this finding, approval of the 
NDA's listed above, and all amendments and supplements thereto, is 
hereby withdrawn, effective November 17, 1997.

    Dated: November 6, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-30148 Filed 11-14-97; 8:45 am]
BILLING CODE 4160-01-F