[Federal Register Volume 73, Number 6 (Wednesday, January 9, 2008)]
[Notices]
[Page 1619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-190]
[[Page 1619]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007P-0295]
Determination That INDERAL (Propranolol Hydrochloride) Tablets,
10 Milligrams, 20 Milligrams, and 90 Milligrams Were Not Withdrawn From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
INDERAL (propranolol hydrochloride (HCl)) Tablets, 10 milligrams (mg),
20 mg, and 90 mg, were not withdrawn from sale for reasons of safety or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 the drug products, and it will allow FDA to
approve ANDAs for propranolol HCl tablets, 10 mg, 20 mg, and 90 mg as
long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Mary Catchings, 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 (Public Law 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. 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 (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, drugs are removed 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 or (2) whenever a listed drug is voluntarily
withdrawn from sale, and ANDAs that referred to the listed drug have
been 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 initiate proceedings that could result in the
withdrawal of approval of the ANDAs that refer to the listed drug. FDA
may not approve an ANDA that does not refer to a listed drug.
INDERAL (propranolol HCl) Tablets, 10 mg, 20 mg, 40 mg, 60 mg, 80
mg, and 90 mg, are the subject of approved NDA 16-418 held by Wyeth
Pharmaceuticals, Inc. (Wyeth). INDERAL is indicated in the treatment of
hypertension, angina pectoris, atrial fibrillation, myocardial
infarction, migraine headaches, essential tremors, hypertrophic
subaortic stenosis, and pheochromocytoma. In tablet form, INDERAL is
currently available in 40-, 60-, and 80-mg strengths. Wyeth
discontinued marketing the tablet form in the 10-, 20-, and 90-mg
strengths, and those products were moved from the prescription drug
product list to the ``Discontinued Drug Product List'' section of the
Orange Book.
In a citizen petition dated July 20, 2007 (Docket No. 2007P-0295/
CP1), submitted under 21 CFR 10.25(a) and 10.30, Regulus Pharmaceutical
Consulting, Inc., requested that the agency determine, as described in
Sec. 314.161, whether INDERAL (propranolol HCl) Tablets, 10 mg and 20
mg, were withdrawn from sale for reasons of safety or effectiveness.
The petitioner has identified no data or other information suggesting
that INDERAL Tablets, 10 mg and 20 mg, were withdrawn from sale as a
result of safety or effectiveness concerns. Although the citizen
petition did not address the 90-mg strength, FDA must make a
determination regarding whether that strength was withdrawn for safety
or efficacy reasons because generic versions of that strength are
currently being marketed.
We have reviewed our records and determined that INDERAL Tablets,
10 mg, 20 mg, and 90 mg, were not withdrawn from sale for reasons of
safety or effectiveness. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events and have
found no information that would indicate that INDERAL Tablets, 10 mg,
20 mg, and 90 mg, were withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petition and reviewing its records,
FDA has determined that, for the reasons outlined in this notice,
INDERAL (propranolol HCl) Tablets, 10 mg, 20 mg, and 90 mg, were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list INDERAL (propranolol HCl)
Tablets, 10 mg, 20 mg, and 90 mg, 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 INDERAL (propranolol HCl) Tablets,
10 mg, 20 mg, and 90-mg, may be approved by the agency as long as they
comply with relevant legal and regulatory requirements. 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: January 2, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-190 Filed 1-8-08; 8:45 am]
BILLING CODE 4160-01-S