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Docket ID: [Docket No. FDA-2007-D-0369] (formerly Docket No. 2007D-0168)

NOTICE: NOTICES

ACTION: Meetings:

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

DATES: Submit written or electronic comments on the draft product- specific BE recommendations listed in this notice by December 4, 2008.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft productspecific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

SUMMARY: Product-Specific Bioequivalence Recommendations; Publication of Guidances for Industry,

SUPPLEMENTAL INFORMATION

In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' that explained the process that would be used to make productspecific BE recommendations available to the public on FDA's Web site at http:// www.fda.gov/CDER/GUIDANCE/bioequivalence/default.htm. As described in that draft guidance, FDA adopted this process as a means to develop and disseminate productspecific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Since that notice was published we have published a correction notice concerning Bioequivalence Recommendations for Specific Products on October 25, 2007 (72 FR 60683). This notice includes draft productspecific recommendations either newly posted or updated since the Federal Register notice dated October 25, 2007, through April 30, 2008.
II. Drug Products for Which New Draft ProductSpecific BE

Recommendations Are Available

The following draft BE productspecific recommendations have been newly posted since the FR notice dated October 25, 2007:
(1) Abacavir Sulfate; Lamivudine
(2) Alendronate Sodium
(3) Alfuzosin HCl
(4) Alprazolam
(5) Amoxicillin; Clavulanate Potassium (multiple RLDs)
(6) Amprenavir
(7) Aripiprazole
(8) Armodafinil
(9) Atovaquone
(10) Azithromycin
(11) Balsalazide Disodium
(12) Bupropion HCl (updated)
(13) Carbamazepine (multiple dosage forms)
(14) Cefdinir
(15) Cefixime
(16) Cetirizine HCl; Pseudoephedrine HCl
(17) Ciprofloxacin; Ciprofloxacin HCl
(18) Ciprofloxacin HCl
(19) Clarithromycin
(20) Darunavir Ethanolate
(21) Delavirdine Mesylate
(22) Dexmethylphenidate
(23) Diltiazem HCl (multiple dosage forms; multiple RLDs) (24) Divalproex Sodium
(25) Doxycycline (multiple dosage forms)
(26) Eprosartan Mesylate; Hydrochlorothiazide
(27) Esterified Estrogens
(28) Eszopiclone
(29) Ethambutol HCl
(30) Ethinyl Estradiol; Levonorgestrel (multiple RLDs)
(31) Fenofibrate
(32) Fluvastatin Sodium (multiple dosage forms)
(33) Fosamprenavir Calcium
(34) Glimepiride; Rosiglitazone Maleate
(35) Lamivudine
(36) Linezolid
(37) Lisinopril
(38) Lopinavir; Ritonavir
(39) Memantine HCl
(40) Mesalamine
(41) Metoprolol Succinate (updated)
(42) Minocycline HCl
(43) Nelfinavir Mesylate
(44) Nevirapine
(45) Omeprazole; Sodium Bicarbonate; Magnesium Hydroxide (46) Oxymorphone HCl (multiple dosage forms)
(47) Paliperidone
(48) Paricalcitol
(49) Phenytoin
(50) Pimozide
(51) Posaconazole
(52) Quinine Sulfate
(53) Saquinavir Mesylate (multiple dosage forms)
(54) Solifenacin Succinate
(55) Tenofovir Disoproxil Fumarate
(56) Tinidazole
(57) Tipranavir
(58) Tolterodine Tartrate
(59) Tramadol HCl
(60) Trospium Chloride
(61) Varenicline Tartrate
(62) Zafirlukast
(63) Zalcitabine
(64) Zileuton
(65) Zolmitriptan
(66) Zonisamide
III. Drug Products for Which Updated Draft ProductSpecific BE Recommendations Are Available

The following five productspecific recommendations previously made available on FDA's Web site have been updated:

1. Risedronate Sodium

2. Fosinopril Sodium; Hydrochlorothiazide

3. Fluoxetine HCl; Olanzapine

4. Erlotinib HCl

5. Morphine Sulfate
For a complete history of previous Federal Register notices pertaining to productspecific BE recommendations, please go to http:// www.regulations.gov and enter FDA2007D0369.

IV. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on any of the specific BE recommendations posted on FDA's Web site. Two copies of mailed comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance, notices, and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Governmentwide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only at http://www.regulations.gov. V. Electronic Access

Persons with access to the Internet may obtain the document at either http:// www.regulations.gov.

Dated: August 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E820580 Filed 9408; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Doan T. Nguyen, Center for Drug Evaluation and Research (HFD600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 2402769314.