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GXPNews.com - FDA News and Announcements - June 02, 2008 - June 06, 2008
The once a week newsletter reporting on what's new within the Food and Drug Administration (FDA)

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Center for Drug Evaluation &
Research (CDER) News

Center for Biologics Evaluation & Research (CBER)

Center for Device &
Radiological Health (CDRH)

Federal Register - Meetings, Notices, & Rule Changes

June 6, 2008

Adverse Event Reporting System (AERS) Statistics
FDA issues a Follow-up to the March 27, 2008 Communication about the Ongoing Safety Review of Regranex (becaplermin). Information
Guidance for Industry: Q3A(R) Impurities in New Drug Substances [PDF]

June 5, 2008

Drugs to be Discontinued
Information on Heparin Sodium Injection (updated)
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
New and Generic Drug Approvals
- Antara (fenofibrate) Capsules, Oscient Pharmaceuticals, Labeling Revision
- BARACLUDE (entecavir) Tablets, Bristol-Myers Squibb Company, Labeling Revision
- BARACLUDE (entecavir) Oral Solution, Bristol-Myers Squibb Company, Labeling Revision
- Carbidopa and Levodopa Tablets, Apotex Corp., Approval
- Carbinoxamine Maleate Tablets, Boca Pharmacal, Inc., Approval
- ChloraPrep (chlorhexidine gluconate and isopropyl alcohol) Sponge, Enturia, Inc., Formulation Revision
- Lovaza (omega-3-acid ethyl esters) Capsules, Reliant Pharmaceuticals, Inc., Labeling Revision
- Mirena (levonorgestrel) Intrauterine Device, Bayer Healthcare Pharmaceuticals, Inc., Labeling Revision
- Moexipril Hydrochloride Tablets, Apotex Corp., Approval
- OxyContin (oxycodone hydrochloride) Extended-Release Tablets, Purdue Pharma LP, Labeling Revision
- Potassium Chloride Extended-Release Capsules, Andrx Pharmaceuticals, LLC, Approval
- Propranolol Hydrochloride Tablets, Ipca Laboratories, Ltd., Approval
- Reclast (zoledronic acid) Injection, Novartis Pharmaceuticals Corp., New or Modified Indication
- SPRYCEL (dasatinib) Tablets, Bristol-Myers Squibb Co., Control Supplement
- Stavudine Oral Solution, Aurobindo Pharma USA, Inc., Tentative Approval
- Tradename To Be Determined (mesalamine) Delayed-Release Tablets, Procter & Gamble Pharmaceuticals, Approval

June 4, 2008

Drugs@FDA Downloadable Data Files (updated)
FDA issues an Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia).
New and Generic Drug Approvals
- Furadantin (nitrofurantoin) Oral Suspension, Sciele Pharma, Inc., Labeling Revision
- Hydrochlorothiazide Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
- Omeprazole Delayed-Release Capsules, Andrx Pharmaceuticals, LLC, Approval
- ORTHO-CYCLEN (norgestimate and ethinyl estradiol) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Formulation Revision
- ORTHO TRI-CYCLEN (norgestimate and ethinyl estradiol) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Formulation Revision
- Valsartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- VFEND (voriconazole) Tablets, Pfizer, Inc., Labeling Revision
- VFEND (voriconazole) Injection, Pfizer, Inc., Labeling Revision
- VFEND (voriconazole) Oral Suspension, Pfizer, Inc., Labeling Revision
- Welchol (colesevelam hydrochloride) Tablets, Daiichi Sankyo, Inc., Manufacturing Change or Addition

June 3, 2008

Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated)
Ombudsman’s Annual Report for 2007

June 2, 2008

Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
Guidance for Industry: Indexing Structured Product Labeling [PDF]
New and Generic Drug Approvals
- Accolate (zafirlukast) Tablet, AstraZeneca Pharmaceuticals LP, Labeling Revision
- Acetaminophen and Codeine Phosphate Tablets, Interpharm, Inc., Approval
- Alprazolam Extended-Release Tablets, Interpharm, Inc., Approval
- Amantadine Hydrochloride Capsules, Banner Pharmacaps, Inc., Approval
- Caduet (amlodipine besylate and atorvastatin calcium) Tablets, Pfizer Global Pharmaceuticals, Inc., Labeling Revision
- Cefpodoxime Proxetil Tablets, Sandoz, Inc., Approval
- Cetirizine Hydrochloride Syrup, Teva Pharmaceuticals USA
- Clobetasol Propionate Lotion, Actavis Mid Atlantic, LLC, Tentative Approval
- Ethosuximide Capsules, Covenant Pharma, Inc., Approval
- Hydroxyzine Hydrochloride Tablets, Hetero Drugs, Ltd., Approval
- Lotensin (benazepril hydrochloride) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Lotensin HCT (benazepril hydrochloride and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Midazolam Hydrochloride Injection, Wockhardt USA, Inc., Approval
- Mometasone Furoate Cream, Glenmark Generics, Inc., USA, Approval
- Mometasone Furoate Ointment, Glenmark Generics, Inc., USA, Approval
- Mirena (levonorgestrel) Intrauterine Device, Bayer Healthcare Pharmaceuticals, Inc., Labeling Revision
- Ropinirole Hydrochloride Tablets, Wockhardt USA, Inc., Approval
- Temazepam Capsules, Mutual Pharmaceutical Company, Inc., Tentative Approval
- Topiramate Tablets, Lupin Pharmaceuticals, Inc., Tentative Approval

CDER Drug Links

Supplement Approval: Tetanus and Diphtheria Toxoids Adsorbed (TENIVAC)
Posted: 6/6/2008, Approval Date: 6/5/2008

ICH; Guidance for Industry: Q3A Impurities in New Drug Substances
Posted: 6/5/2008

Approved Biological NDA and ANDA Applications - Update
Posted: 6/5/2008, Updated through: 5/31/2008

Cleared Biological 510(k) Device Applications - Update
Posted: 6/5/2008, Updated through: 5/31/2008

Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 6/5/2008, Updated through: 5/31/2008

Substantially Equivalent 510(k) Device - PCS2 Plasma Collection System_Revision K software - Haemonetics Corp
Posted: 6/4/2008, Clearance Date: 5/28/2008

Vacancy Announcement - Program Support Assistant (OA), OD/OVRR
Posted: 6/4/2008

CBER Links

June 6, 2008
	Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Agenda, Roster, Briefing, Questions

June 5, 2008
	Summary Information for: Stratos LV CRT-P and Stratos LV-T CRT-P, Corox OTW BP Lead and Corox OTW-S BP Lead

June 2, 2008
	Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments .
	Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments.

Medical Device Links

EU GMPs & US GMPs

Weekly Rule Changes
Part(s)

Friday, June 06, 2008

NOTICES
Compliance Policy Guide Sec. 560.700; Processing of Imported Frozen Products of Multiple Sizes (e.g., Shrimp, Prawns, etc.) (CPG 7119.10):
Withdrawal of Guidance,
32338 [E8–12766] [TEXT] [PDF]

Thursday, June 05, 2008

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
32029–32030 [E8–12648]   [TEXT]  [PDF]

Meetings:
     Advisory Committee for Pharmaceutical Science and Clinical Pharmacology,
     32030–32031 [E8–12647]   [TEXT]  [PDF]
     Arthritis Advisory Committee,
     32031–32032 [E8–12646]   [TEXT]  [PDF]

Wed., June 04, 2008

NONE

Tuesday, June 03, 2008

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals,
31692–31693 [E8–12297]   [TEXT]  [PDF]
31693–31694 [E8–12302]   [TEXT]  [PDF]
31694–31695 [E8–12337]   [TEXT]  [PDF]
31696–31697 [E8–12339]   [TEXT]  [PDF]

Determination of Regulatory Review Period for Purposes of Patent Extension:
     TYZEKA; Correction,
     31697 [E8–12300]   [TEXT]  [PDF]
     VEREGEN,
     31697–31698 [E8–12296]   [TEXT]  [PDF]

Meetings:
     Food Labeling Workshop; Public Workshop,
     31698–31699 [E8–12301]   [TEXT]  [PDF]
     Preparation for International Cooperation on Cosmetics Regulations; Washington, DC,
     31699–31700 [E8–12338]   [TEXT]  [PDF]

Monday, June 02, 2008

RULES
Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol
31357–31358 [E8–12160]   [TEXT]  [PDF]
Medical Devices; Hearing Aids; Technical Data Amendments,
31358–31360 [E8–11910]   [TEXT]  [PDF]

PROPOSED RULES
Medical Devices; Hearing Aids; Technical Data Amendments,
31390–31392 [E8–11909]   [TEXT]  [PDF]

NOTICES
Food Safety Research; Investigations Focused on Promoting the Safety of Produce,
31490–31492 [E8–12159]   [TEXT]  [PDF]

Guidance for Industry on Indexing Structured Product Labeling; Availability,
31492–31493 [E8–12158]   [TEXT]  [PDF]

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FDA Handbooks

EU - US - ICH GMP
Combination Product handbook

US GMP Training Booklet

Std. GMPs - Parts 11, 210, 211, 820 & ICH Q7

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Clinical GCP - Parts 11, 50, 54, 56, 312, 314 & ICH E2A & E6

Multi-US GMPs 11, 58, 210/211, 600, 601, 610 & 820

Parts 210/211 - Drug GMPs

>210/211 with Part 11

>210/211 with Part 820

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>210/211 w/ Keyword Index

Part 820 Quality Systems Regs

Part 58 - GLP Good Lab. Practice

Part 11 - Electronic Records w/ Scope and Applications

GLP 2 11 & 58 - Part 11 & 58

PDMA 11, 203 & 205 - Prescription Drug Marketing

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11 & 820 Electronic Record and Quality Systems

Biological GMPs 600, 601, 610

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GXPNews.com - FDA News and Announcements - June 02, 2008 - June 06, 2008 The once a week newsletter reporting on what's new within the Food and Drug Administration (FDA)