[Federal Register Volume 61, Number 159 (Thursday, August 15, 1996)]
[Notices]
[Page 42428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20857]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket Nos. 96P-0190/CP1, 96P-0197/CP1, 96P-0251/CP1]
Determination That Selegiline Hydrochloride 5-Milligram Tablet
Was Not Withdrawn From Sale For Reasons of Safety or Effectiveness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
selegiline hydrochloride (Eldepryl) 5-milligram (mg) tablet
was not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDA's) for selegiline hydrochloride 5-mg tablet.
FOR FURTHER INFORMATION CONTACT: Andrea C. Masciale, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-2041.
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
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,'' which is 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 Under FDA regulations, drugs are withdrawn from the list if the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listed drug was withdrawn from sale for reasons of safety or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). Regulations also provide that 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
(Sec. 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an
ANDA that does not refer to a listed drug.
-Selegiline hydrochloride (Eldepryl) 5-mg tablet is the
subject of approved NDA 19-334, held by Somerset Pharmaceuticals, Inc.
(Somerset). On May 17, 1996, Somerset withdrew the selegiline
hydrochloride 5-mg tablet from sale, and began marketing in its place a
capsule form of selegiline hydrochloride 5-mg (NDA 20-647).
-On June 12, 1996, Novopharm Ltd. submitted under 21 CFR 10.30 a
citizen petition (Docket No. 96P-0190/CP1) regarding the status of the
selegiline hydrochloride 5-mg tablet. Two similar citizen petitions
were subsequently received by the agency; a petition by Endo
Laboratories, L.L.C. was filed on June 17, 1996 (Docket No. 96P-0197/
CP1), and a petition submitted by Williams & Connolly on behalf of
Alphapharm, Ltd. was filed on July 10, 1996 (Docket No. 96P-0251/CP1).
The three petitions request that the agency determine whether the
selegiline hydrochloride 5-mg tablet was withdrawn from sale for
reasons of safety or effectiveness and, if the agency determines that
the drug was not withdrawn from sale for reasons of safety or
effectiveness, keep the drug listed in the Orange Book.
-The agency has reviewed its records and under Sec. 314.161, has
determined that the selegiline hydrochloride 5-mg tablet was not
withdrawn from sale for reasons of safety or effectiveness. In reaching
its decision, FDA considered comments submitted by Somerset, in which
Somerset asserted that the drug was withdrawn from sale for safety
reasons. Somerset requested that FDA deny the citizen petitions.
-Somerset claims that Eldepryl 5-mg tablet was withdrawn
from the market ``out of concern for the safety of patients with
Parkinson's Disease.'' First, it refers to the appearance of
counterfeit Eldepryl tablets in the U.S. marketplace. This is
not a problem unique to Eldepryl and is not evidence that the
product is unsafe.
-Second, Somerset makes a nonspecific reference to ``the
information contained in NDA # 19-334'' as confirmation that the
removal of the tablet form of the drug was out of concern for the
safety of patients. FDA's examination of this NDA found no evidence to
support this claim. Somerset may have been alluding to reports of
difficulty swallowing tablets in patients with Parkinson's Disease.
That some patients may prefer an alternative dosage form is common with
oral products regardless of the disease being treated. FDA does not
regard providing a second dosage form that some patients may find more
convenient than the first as evidence that the first is unsafe.
Somerset may also have been alluding to reports of confusion between
Eldepryl tablets and enalapril. This is not a safety concern
relevant to generic products because, among other reasons, they would
not use the name Eldepryl .
-The agency concludes that Eldepryl tablets were
withdrawn from sale for reasons other than for safety or effectiveness.
Accordingly, the agency will maintain selegiline hydrochloride 5-mg
tablet 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. ANDA's that refer to
selegiline hydrochloride 5-mg tablet may be approved by the agency.
Dated: August 9, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-20857 Filed 8-14-96; 8:45 am]
BILLING CODE 4160-01-F