[Federal Register Volume 65, Number 120 (Wednesday, June 21, 2000)]
[Notices]
[Page 38562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15630]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P-0090]


Determination That Paroxetine Hydrochloride 10-, 20-, 30-, and 
40-Milligram Capsules Were Not Withdrawn From Sale for Reasons of 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 
paroxetine hydrochloride (Paxil) 10-, 20-, 30-, and 40-milligram (mg) 
capsules were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDA's) for paroxetine hydrochloride 10-, 20-, 
30-, and 40-mg capsules.

FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20855, 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 approved 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 under a new drug 
application (NDA). Sponsors of ANDA's do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of an 
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 included what is now section 505(j)(6) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(6)), 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Under FDA regulations, drugs are withdrawn from the list if the agency 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 
(Sec. 314.162 (21 CFR 314.162)). Under Sec. 314.161(a)(1) (21 CFR 
314.161(a)(1)) the agency must make a determination as to whether a 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness before an ANDA that refers to that listed drug may be 
approved. FDA may not approve an ANDA that does not refer to a listed 
drug.
    In a citizen petition dated December 28, 1999 (Docket No. 00P-0090/
CP1), submitted under 21 CFR 10.25(a), 10.30, and 314.122, Pentech 
Pharmaceuticals, Inc., requested that the agency determine whether 
paroxetine hydrochloride (Paxil) 10-, 20-, 30-, and 40-mg capsules were 
withdrawn or withheld from sale for reasons of safety or effectiveness. 
Paroxetine hydrochloride (Paxil) 10-, 20-, 30-, and 40-mg capsules are 
the subject of approved NDA 20-885 held by SmithKline Beecham 
Pharmaceuticals (SKB). SKB obtained approval to market the 10-, 20-, 
30-, and 40-mg strengths of paroxetine hydrochloride capsules on 
October 9, 1998. SKB has never marketed the 10-, 20-, 30-, and 40-mg 
strengths of paroxetine hydrochloride capsules. FDA has determined, for 
purposes of Secs. 314.161 and 314.162(c), that never marketing an 
approved drug product is equivalent to withdrawing the drug from sale.
    FDA has reviewed its records and, under Secs. 314.161 and 
314.162(c), has determined that paroxetine hydrochloride 10-, 20-, 30, 
and 40-mg capsules were not withdrawn from sale for reasons of safety 
or effectiveness. Accordingly the agency will maintain paroxetine 
hydrochloride 10-, 20-, 30-, and 40-mg capsules 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. ANDA's that refer to paroxetine hydrochloride 10-, 20-, 
30-, and 40-mg capsules may be approved by the agency.

    Dated: June 14, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-15630 Filed 6-20-00; 8:45 am]
BILLING CODE 4160-01-F