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[Federal Register Volume 66, Number 35 (Wednesday, February 21, 2001)]
[Notices]
[Page 11034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4229]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0057]

Determination That Bethanechol Chloride Injection and Tablets 
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
bethanechol chloride 5 milligrams (mg) per milliliter (mL) injection 
and bethanechol chloride 5-, 10-, 25-,
and 50-mg tablets, all formerly marketed by Merck & Co., Inc. (Merck), 
were not withdrawn from sale for reasons of safety or effectiveness.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 (ANDA's) for bethanechol 
chloride drug products, and it will also allow FDA to continue to 
approve ANDA's for bethanechol chloride drug products.

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

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (the 1984 
amendments) (Public Law 98-417), which authorized the approval of 
duplicate versions of drug products under an ANDA procedure. ANDA 
sponsors 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. Sponsors of ANDA's 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 to which the 
ANDA refers.
    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,'' generally known as the ``Orange Book.'' 
Under FDA regulations, drugs are 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)(2) (21 CFR 314.161(a)(2)) the agency 
must make a determination as to whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness if ANDA's that refer 
to the drug that was withdrawn are approved. Section 314.161(d) 
provides that if FDA determines that the listed drug was removed from 
sale for safety or effectiveness reasons, the agency will begin 
proceedings to withdraw approval of the ANDA's that refer to the drug 
that was withdrawn from sale.
    FDA has received a letter, dated April 7, 2000, from Merck, holder 
of NDA 6-536 for bethanechol chloride 5-mg/mL injection and bethanechol 
chloride 5-, 10-, 25-, and 50-mg tablets, stating that Merck has 
withdrawn those products from sale. Danbury Pharmacal, Inc., Roberts 
Laboratories, Inc., Glenwood, Inc., and Sidmak Laboratories, Inc. 
(Sidmak), all hold approved ANDA's that refer to one or more of Merck's 
bethanechol chloride drug products. Merck sold its bethanechol chloride 
drug products under the trade name of Urecholine. In their April 7, 
2000, letter, Merck also informed FDA that Merck has assigned the 
trademark Urecholine to Sidmak for use in the sale of Sidmak's 
bethanechol chloride drug products.
    FDA has reviewed its records and, under Sec. 314.161, has 
determined that bethanechol chloride 5-mg/mL injection and bethanechol 
chloride 5-, 10-, 25-, and 50-mg tablets were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the agency will 
list Merck's bethanechol chloride 5-mg/mL injection and bethanechol 
chloride 5-, 10-, 25-, and 50-mg tablets 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. The approval status of the ANDA's that refer to 
bethanechol chloride 5-mg/mL injection and bethanechol chloride 5-, 10-
, 25-, and 50-mg tablets is unaffected. ANDA's for bethanechol chloride 
5-mg/mL injection and bethanechol chloride 5-, 10-, 25-, and 50-mg 
tablets may be approved by the agency.

    Dated: February 14, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-4229 Filed 2-20-01; 8:45 am]
BILLING CODE 4160-01-F
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