[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10 Milligrams, 20 Milligrams, and 90 Milligrams Were Not Withdrawn From 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20 mg, and 90 mg, were not withdrawn from sale for reasons of safety or 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