Guidance for Industry

Submitted by sharon on Thu, 05/01/2008 - 14:10.

New/Revised/Withdrawn List for 2008

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Feed: Center for Drug Evaluation and Research
Original article

Drug News and Information

Drug News


FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
Regranex (becaplermin) Gel
Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)
Diabetes Gel Regranex Linked to Cancer
Bad Bacteria Lurk in Rest Stops
Can Red Wine Help You Live Longer?
Gum Disease May Make Diabetes Worse
Health Perks of Garlic: Fresh Is Best
2 Diabetes Studies Give Mixed Message
Specialty pharmacies selected for Cinryze, which is poised for approval

Drug Alerts


Possible lymphoma link to TNF-blockers sparks agency review
FDA proposes new pregnancy categories for prescription label
FDA requests recall of Xiadafil VIP Tabs
FDA warns that nipple cream can hurt nursing babies
Azathioprine (Azasan) tablets found in minocycline (Solodyn) bottle lead to recall
FDA to pharmacies: Don't dispense Scientific Laboratories products
Cardinal Health mouthwash being recalled
Warning of bacterial sepsis and tuberculosis added to etanercept prescribing information
Neupro patches recalled due to crystallization
PML in CellCept users leads to early warning

Drug Latebreakers


NovoNordisk NovoLog approved for use in insulin pumps by children and adolescents
Bendamustine approved by FDA for chronic lymphocytic leukemia
Medicare Part B expands coverage for warfarin patients monitoring clotting time at home
CMS outlines 2009 Part D plan requirements
APhA and NACDS Foundation launch medication therapy management Version 2.0
DMEPOS competitive bidding program logs 26% discount in first round
CVS Caremark Corp. to pay almost $37 million on retail dispensing practices for ranitidine
Walgreens expands into work site clinics with acquisitions
CMS issues new rule on multiple-source drugs
Latebreakers: USA Today puts focus on medication errors

New Drug Approvals


Entereg helps restore bowel function in hospitalized patients
Quetiapine (Seroquel) approved by FDA as maintenance treatment of bipolar I disorder
Taclonex Scalp is approved by the FDA for scalp psoriasis
NovoSeven RT is FDA approved and can be stored at room termperature
Methylnaltrexone bromide (Relistor) is approved by the FDA for opioid-induced constipation
Alcon announces FDA approval of olopatadine Hcl (Patanase) nasal spray for seasonal allergies
FDA approves new treatment for chronic lymphocytic leukemia
Cimzia approved for signs and symptoms of Crohn's disease
Atomoxetine approved by FDA for maintenance ADHD
Lisdexamfetamine granted approval for ADHD in adults

Recalls


FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)
FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes
Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30)
Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder
Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27)
International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary
Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names
Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B0
FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16)

Drug Surveys


Drug Topics' over-the-counter allergy products survey January, 2008
2007 Drug Topics OTC Cough, Cold, and Flu survey
2007 Drug Topics OTC recommendations survey

New Products

New Rx


Biovail receives approval for Aplenzin for depression
Vyvanse approved to treat adults with ADHD
Treximet, a sumatriptan and naproxen combination treatment, approved for migraine
Nasal spray for allergies to launch next month
Compassionate use of mifamurtide available for osteosarcoma
Intelence: New HIV drug is smart choice for some
Orphan drug gets FDA nod for phenylketonuria
This breast cancer drug is first in new class of chemo agents
First-in-class HIV treatment gets green light
Another antihypertensive combo approved

New Over the Counter


New over-the-counter eye health products
Rite Aid rolls out Identigene's OTC DNA paternity test kit
New OTCs just in time for allergy season
Get ready to usher in these new OTCs

New Health Beauty


Tip sheet explains referrals, grandfathered suppliers for DMEPOS program
No Content Available for Pharmacist news & clinical info from Drug Topics. Daily news and current clinical info on OTC m

New Home Health Care


FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
Regranex (becaplermin) Gel
Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)
Gum Disease May Make Diabetes Worse
Can Red Wine Help You Live Longer?
Health Perks of Garlic: Fresh Is Best
Diabetes Gel Regranex Linked to Cancer
Bad Bacteria Lurk in Rest Stops
2 Diabetes Studies Give Mixed Message
FDA: Possible Risk From Dental Fillings

Other New Products


BPCA/Pediatric Exclusivity Statistics: List of Determinations Including Written Request (updated)
Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol)
Drug Safety Oversight Board Meeting, March 20, 2008 Public Summary
Prescription Drug User Fee Act (PDUFA) Billable Products
Enbrel (etanercept)
Guidance for Industry
Guidance for Industry
Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs (up
FDA Approves Amitiza for IBS-C
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies