[Federal Register Volume 59, Number 250 (Friday, December 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-32138]
[[Page Unknown]]
[Federal Register: December 30, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0184]
Barr Laboratories, Inc.; Withdrawal of Proposal To Refuse To
Approve Certain Abbreviated Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing a notice
proposing to refuse to approve certain original and supplemental
abbreviated new drug applications (ANDA's) and certain original and
supplemental abbreviated antibiotic applications (AADA's) submitted by
Barr Laboratories, Inc., 2 Quaker Rd., Pomona, NY 10970 (Barr). That
notice also provided Barr with an opportunity for a hearing. The basis
for this withdrawal is Barr's present compliance with current good
manufacturing practice (CGMP), so that the methods Barr uses in, and
the facilities and controls it uses for, the manufacturing, processing,
and packing of its drug products are adequate to assure and preserve
its products' identity, strength, quality, and purity.
EFFECTIVE DATE: December 30, 1994.
FOR FURTHER INFORMATION CONTACT: Harry T. Schiller, Center for Drug
Evaluation and Research (HFD-366), Food and Drug Administration, 7500
Standish Place, Rockville, MD 20855, 301-594-2041.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of May 28, 1993 (58 FR 31035)), FDA proposed to refuse to
approve certain original and supplemental ANDA's and AADA's submitted
by Barr. The basis for the proposal was that the drug products that
were the subjects of these original applications and supplements were
not being manufactured in compliance with the CGMP regulations. A
detailed description of the deficiencies and the basis for the agency's
proposal can be found in the May 28, 1993, Federal Register notice. In
a notice of opportunity for hearing (NOOH), the agency proposed to
refuse approval of the following original ANDA's and AADA's:
AADA 63-291, Minocycline Hydrochloride Capsules, 100 milligrams
(mg);
AADA 63-309, Minocycline Hydrochloride Tablets, 100 mg;
AADA 63-319, Minocycline Hydrochloride Tablets, 50 mg;
ANDA 72-916, Sulindac Tablets, 200 mg;
ANDA 72-964, Sulindac Tablets, 150 mg;
ANDA 74-049, Atenolol Tablets, 50 mg and 100 mg.
In the notice, FDA also proposed to refuse to approve the following
supplemental ANDA's and AADA's:
AADA 62-418/S-014, Doxycycline Hyclate Capsules, 50 and 100 mg;
AADA 62-773/S-005, Cephalexin Capsules, 250 mg;
AADA 62-827/S-006, Cephalexin Tablets, 500 mg;
ANDA 70-060/S-012, S-017, Methyldopa Tablets, 250 mg;
ANDA 70-080/S-028, S-029, Ibuprofen Tablets, 600 mg;
ANDA 70-103/S-018, S-019, Propranolol Hydrochloride Tablets, 40 mg;
ANDA 70-319/S-018, S-019, Propranolol Hydrochloride Tablets, 10 mg;
ANDA 70-320/S-018, Propranolol Hydrochloride Tablets, 20 mg;
ANDA 70-472/S-004, Lorazepam Tablets, 0.5 mg;
ANDA 70-474/S-004, S-010, Lorazepam Tablets, 2 mg;
ANDA 70-765/S-010, S-011, S-012, S-013, Chlordiazepoxide and
Amitriptyline Hydrochloride Tablets, 5 mg/12.5 mg;
ANDA 71-212/S-003, S-009, Haloperidol Tablets, 5 mg;
ANDA 71-251/S-005, Triamterene and Hydrochlorothiazide Tablets, 75
mg/50 mg;
ANDA 71-462/S-014, S-015 Ibuprofen Tablets, 200 mg;
ANDA 80-701/S-079, Prednisone Tablets, 5 mg;
ANDA 84-106, S-065, S-066, Hydralazine Hydrochloride Tablets, 25
mg;
ANDA 84-600/S-039, Dicyclomine Hydrochloride Tablets, 20 mg;
ANDA 88-488/S-013, Hydroxyzine Pamoate Capsules, 100 mg.
Following the publication of the NOOH, the agency inspected Barr's
Northvale, NJ, manufacturing facility from May 2, 1994, through June
10, 1994. FDA also inspected Barr's Pomona, NY, manufacturing facility
from June 16 through July 18, 1994. Based on these inspections, the
firm's responses to the FDA investigators' observations, and the
resolution by consent decree of enforcement litigation concerning
Barr's compliance with the CGMP regulations (United States v. Barr
Laboratories, Inc., Civ. No. 92-2684 (S.D.N.Y.)), FDA has concluded
that Barr is now complying with the CGMP regulations in manufacturing
drug products. Accordingly, the May 28, 1993, Federal Register notice
proposing to refuse to approve certain applications and supplements is
withdrawn. The withdrawal of the Federal Register notice does not
constitute approval of the original applications and supplements; the
agency is continuing its review of those applications and supplements
to ensure that they meet all statutory requirements for approval in
addition to compliance with CGMP. This notice is issued under the
Federal Food, Drug, and Cosmetic Act (sec. 505 (21 U.S.C. 355)) and
under the authority delegated to the Director of the Center of Drug
Evaluation and Research (21 CFR 5.82).
Dated: December 20, 1994.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-32138 Filed 12-29-94; 8:45 am]
BILLING CODE 4160-01-F
