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Drug News

May 15, 2008
  • Trasylol withdrawn from market
May 14, 2008
  • FDA approves Seroquel for bipolar maintenance
  • Generic Paxil CR launched
May 12, 2008
  • FDA approves Taclonex Scalp for psoriasis
  • Generic Yasmin approved
  • NovoSeven RT approved to control surgical bleeding
  • OraVerse approved for dental anesthetic recovery
May 9, 2008
  • Abilify gains expanded bipolar and schizophrenia indications
May 8, 2008
  • FDA approves Strattera for ADHD maintenance
May 6, 2008
  • Generic Dovonex scalp solution launched
May 5, 2008
  • King discontinues Tilade Inhaler
  • Metamucil Pink Lemonade available
May 1, 2008
  • Advair gains COPD indications
  • ► April 2008
    • Amitiza gains IBS-C indication
    • FDA approves MixJect system for Trelstar
    • All lots of Digitek tablets recalled
    • OneTouch UltraLink Meter now available
    • FDA approves once-a-month Actonel for osteoporosis
    • Relistor approved for OIC
    • Suprax tablets now available
    • FDA approves Aplenzin for depression treatment
    • Vyvanse approved for adult ADHD
    • FDA approves Cimzia for Crohn’s disease
    • Tums QuikPak now available
    • FDA approves Anthelios 40 sunscreen
    • Omnaris available for allergy treatment
    • FDA approves Treximet for migraine treatment
    • Patanase approved for seasonal allergies
    • Abbott launches FreeStyle Freedom Lite monitor
    • Evamist now available for hot flash treatment
    • Luvox CR now available
    • FDA investigates CellCept and Myfortic PML risk
    • Lexiscan approved for MPI testing
    • Geocillin discontinued
    • Lung cancer warning for Exubera
    • Orencia gains JIA indication
    • More Heparin recalled
    • Rotarix vaccine approved for rotavirus prevention
    • Zelnorm treatment IND discontinued
    • Neuropsychiatric warning added to Relenza label
    • Neupro patches recalled
    ► March 2008
    • FDA evaluates Regranex cancer risk
    • FDA investigates suicide risk in Singulair users
    • FDA reviews MI risk in Videx, Ziagen users
    • Pedia-Lax line of products available
    • Revised dosing for Pegintron/Rebetol
    • Heparin Injection Solution recalled
    • Treanda approved for CLL
    • FDA reviews stroke risk in Spiriva users
    • NovoLog for CSII approved for pediatric use
    • Updated labeling for Enbrel
    • FDA approves additional Daptacel dose
    • Granisol oral solution now available
    • Hepatitis warning added to Prezista label
    • FDA issues Tussionex alert
    • Liquadd approved for ADHD
    • Levoleucovorin approved
    • More ESA labeling changes
    • Anestafoam launched for topical pain relief
    • Genzyme launches Renvela
    • FDA issues Tamiflu warning
    • Additional strengths of Opana ER approved
    • Additional strengths of OxyContin available
    • Aloxi gains indication
    • Enlon and Enlon-Plus injection discontinued
    • Pristiq approved for MDD
    ► February 2008
    • Abilify gains pediatric indication
    • Arcalyst approved for CAPS
    • FDA issues advisory for Spiriva and Foradil
    • Luvox CR approved for OCD and SAD
    • Tenormin injection discontinued
    • Teslac tablets discontinued
    • Canasa Pac launched for ulcerative proctitis
    • FDA issues Tysabri warning
    • Nexium approved for pediatric GERD
    • Salonpas pain relief patch approved
    • Avastin receives breast cancer approval
    • Sciele to launch Allegra ODT
    • Atralin gel available for acne
    • Humira gains indication
    • Xyntha approved for hemophilia A
    • Critical Therapeutics discontinues Zyflo
    • Fenoglide launched for cholesterol treatment
    • Additional fentanyl patches recalled
    • Additional Xyzal formulation approved
    • » FDA approves Simcor for cholesterol treatment
    • King launches Altace tablets
    • KwikPen for Humalog and Humalog Mix available
    • Renova 60g tube available
    • Fentanyl 25mcg/hr transdermal patches recalled
    • Generic Pepcid Complete approved
    • Baxter suspends multi-dose heparin production
    • Icy Hot Heat Therapy recalled
    • Humatin capsules discontinued
    • FDA takes action against unapproved injectable colchicine products
    • Duricef oral suspension to be discontinued
    • Generic Fosamax launched
    • Tikosyn shortage resolved
    • Psorent launched for psoriasis
    • Asmanex Twisthaler approved for pediatric asthma
    • FDA warns of suicide risk with antiepileptics
    ► January 2008
    • Emend for injection now available
    • FDA reviews Vytorin and Zetia
    • Accretropin approved for pediatric growth failure
    • Moxatag, an extended-release formulation of amoxicillin approved
    • Bayer launches special access program for Leukine
    • Flector Patch available for pain relief
    • Flo-Pred approved for asthma
    • Humira gains psoriasis indication
    • More indications for Mycamine
    • Welchol gains diabetes indication
    • Additional warnings for Ortho Evra
    • Baxter recalls heparin
    • Intelence approved for HIV treatment
    • Tekturna HCT approved for hypertension
    • Tikosyn 0.25mg and 0.5mg shortage
    • Updated labeling for OTC Claritin
    • Additional warnings for Chantix
    • Recothrom approved to control surgical bleeding
    • FDA warning on children's OTC cough and cold medicines
    • Alvesco approved for asthma
    • Tysabri gains Crohn's disease indication
    • Aveeno launches eczema care product line
    • High purity Thrombin-JMI approved
    • Expanded indication for Evicel
    • Desonate TwinPack available for atopic dermatitis
    • Once-daily Cialis approved
    • Bisphosphonate safety alert
    • SymlinPen now available
    • Additional ESA safety information
    • Generic Kytril approved
    • Additional strengths of Vyvanse approved
    • FDA approves Sular reformulation
    • Luvox returns with OCD indication
    • Higher strength Glumetza tablets approved
    ► December 2007
    • Contour TS Test Strip Recalled
    • Voluven approved for Serious Blood Volume Loss
    • FDA updates fentanyl transdermal warning
    • Lexxel tablets to be discontinued
    • Viadur implants discontinued
    • FDA updates Nonoxynol 9 warning
    • Gelfoam Plus Hemostasis Kit approved to control surgical bleeding
    • Mederma Cream + SPF 30 available
    • Ranexa labeling updated
    • Bystolic approved for hypertension
    • Thyrogen gains thyroid cancer ablation indication
    • Kuvan approved for treating PKU
    • Veregen ointment approved
    • Duet DHA and Duet DHAec available for prenatal supplementation
    • FDA safety alert on carbamazepine
    • PedvaxHIB and COMVAX vaccines recalled
    • FDA concludes Prilosec and Nexium safety review
    • HalfLytely Bowel Prep Kit reformulated
    • Kytril oral solution discontinued
    • Similac launches nipple-ready bottles of infant formula
    • Desmopressin gains warning, loses indication
    • Diovan gains pediatric indication
    • Triesence approved for eye surgery
    ► November 2007
    • Bumex 0.5mg, 2mg tablets discontinued
    • Cymbalta OK'd for maintenance treatment of major depressive disorder
    • Roferon-A discontinued
    • Safety alert for Myfortic
    • Rosula CLK available
    • Unit-dose, preservative-free Tetanus Diphtheria vaccine approved
    • Abilify approved as adjunctive treatment for major depression
    • CitraNatal prenatal vitamins available for women
    • Safety alert for Chantix
    • Avalide approved as initial therapy for hypertension
    • FDA continues ongoing safety review of Cefepime
    • Nexavar approved for liver cancer
    • Zyrtec OTC approved for treating allergies
    • Expanded indication for Seroquel XR
    • Protonix for Delayed-Release Oral Suspension approved
    • Mircera approved for treating anemia in chronic renal failure patients
    • Natelle Plus DHA available for women
    • Cloderm Pump available to treat inflammation and pruritus
    • Fasprin, a no-swallow aspirin tablet available
    • Stronger boxed warning for Avandia
    • Lower-strength Kaletra tablets approved for pediatric patients
    • Procanbid tablets discontinued
    • Zyrtec-D approved for OTC use
    • Crestor gains indication
    • Sprycel labeling update
    • FDA approval of easypod, for use with Saizen
    • FDA strengthens labeling for erythropoiesis-stimulating agents
    • Prometheus to acquire Lotronex
    • Abilify approved for use in adolescents with schizophrenia
    • Marketing suspended for Trasylol
    • Combigan for treating ocular hypertension and glaucoma
    • Coraz Lotion available for treating seborrheic dermatitis
    • Mirapex 0.75mg tablet strength available
    • Pulmicort Respules 1mg ampules available
    • Zytopic Cream available for treating atopic dermatitis
    ► October 2007
    • CellCept use associated with pregnancy loss and congenital malformations
    • Generic Mirapex available
    • Tasigna approved for CML patients
    • Tilia Fe now available
    • TriLegest Fe available
    • Additional warnings for Provigil
    • Aleve-D available for multiple sinus and pain symptoms
    • Renvela approved as a phosphate binder
    • Updated storage conditions for Humate-P
    • Voltaren topical gel 1% for osteoarthritis
    • Expanded labeling for Januvia
    • Menactra OK'd for children 2-10 years of age
    • Potential risk of hearing loss with erectile dysfunction drugs
    • Pfizer discontinues Exubera
    • Epirubicin hydrochloride injection approved in four dosage forms
    • Ixempra approved for advanced breast cancer
    • Lexiva dosing update
    • Safety alert for Byetta
    • Sporanox injection discontinued
    • Doribax approved for complicated intra-abdominal and complicated urinary tract infections
    • Expanded labeling for Velcade
    • Hycamtin capsules approved for small cell lung cancer
    • Isentress tablets approved for HIV infection
    • Amrix available for muscle spasm
    • More Infant's Cough and Cold medications withdrawn
    • Agenerase Oral Solution and 50mg capsules discontinued
    • Generic Trileptal tablets approved
    • Infants' cough and cold products withdrawn from market
    • Generic Actonel tablets approved for marketing
    • Zyprexa and Symbyax labels updated
    • Updated labeling for Erbitux
    • Delsym available in grape-flavor
    • Lamisil Oral Granules for children with tinea capitis
    • Symlin pen-injector devices approved
    • Taxotere approved for treating head and neck carcinoma
    ► September 2007
    • Afluria approved for immunization against flu
    • FDA takes action against unapproved hydrocodone products
    • Zyflo CR available for asthma
    • Azor approved for treating hypertension
    • Generic equivalent for AccuNeb approved
    • Plavix 300mg tablet approved
    • Cytoxan 25mg and 50mg tablets discontinued
    • Generic Equivalents for Penlac and Claritin Syrup approved
    • Norditropin approved for treatment of children with short stature associated with Turner syndrome
    • Expanded labeling for Campath
    • Additional Tylenol products available in Rapid Release Gels
    • Expanded indication for FluMist
    • Tamiflu widely available this flu season
    • Updated labeling for Haldol
    • Levaquin gains additional short-course therapy indications
    • Soma 250mg tablets available
    • Evista approved to reduce breast cancer risk
    • More flu vaccine available
    • Updated safety information for Fentora
    • PreferaOB available for women
    • Generic Coreg tablets approved
    • Lipofen capsules for treating hyperlipidemia
    • Pfizer issues safety alert on Viracept
    • Tersi Foam, a topical fungal treatment
    • Xyralid Cream kit available
    • ACAM2000 vaccine approved for smallpox
    • Limited portion of Daytrana patches withdrawn
    ► August 2007
    • National asthma guidelines updated
    • Evithrom approved for topical use in surgery
    • Eloxatin 200mg single-use vial available
    • Generic Famvir tablets approved
    • More indications for Risperdal
    • MyKidz Iron supplement available for children
    • Reclast approved for once-yearly treatment of postmenopausal osteoporosis
    • Labeling update for warfarin
    • Safety alert for nursing mothers taking codeine
    • Zingo intradermal delivery system approved for topical analgesia
    • Fluvirin vaccine available for early vaccination
    • Stronger warnings for thiazolidinediones
    • Updated labeling for Baraclude
    • Cranberry supplement with Cran-Max
    • Ethmozine 200mg, 250mg, 300mg tablets discontinued
    • Ranexa 1000mg tablet available
    • FDA reviews Prilosec and Nexium safety
    • Fenofibrate 40mg & 120mg approved
    • Generic Cefotetan approved
    • LidoSite transdermal patch analgesic delivery system available
    • ACIP revised recommendations of meningococcal conjugate vaccine
    • Murine Earigate Ear Cleansing System for ear wax buildup
    • Lantus SoloSTAR pen available for hyperglycemia
    • Sanctura XR approved for overactive bladder
    • Selzentry approved for treating HIV
    • Stalevo 200mg dose approved for Parkinson's disease
    ► July 2007
    • Evamist transdermal spray approved
    • Privigen, an intravenous immunoglobulin approved
    • Generic Toprol-XL tablets available
    • Ketotifen Fumarate Ophthalmic Solution, 0.025% approved for relief of itchy eyes
    • Zelnorm will be available under restricted access program
    • Xyralid LP Lotion convenience kit available
    • Extina Foam 2% approved for seborrheic dermatitis
    • A 3000 IU dosage strength of Advate approved
    • Align, a daily probiotic supplement
    • Exelon Patch approved for Alzheimer's and Parkinson's diseases
    • Relafen tablets discontinued
    • Updated labeling for Rocephin
    • Xyralid RC available for treating hemorrhoids
    • AZO Standard Maximum Strength available OTC
    • Generic Lamisil tablets available
    • Tamiflu 30mg and 45mg capsules approved for children
    ► June 2007
    • Kerol Topical Suspension and Rosula Clarifying Wash launched
    • Kogenate FS available in a 2000 IU vial size
    • Ocuvite DF available for diabetics
    • Fosteum available for osteopenia and osteoporosis
    • Generic Adalat CC tablets available
    • Label extensions for Juvederm Ultra and Juvederm Ultra Plus
    • Carnitor SF available for treating carnitine deficiency
    • Endometrin vaginal insert approved
    • Exforge approved for hypertension
    • Lyrica approved for fibromyalgia
    • OTC Thrive gum available for cessation of smoking
    • Prenate DHA launched
    • Differin gel 0.3% approved for acne
    • Safety alert for Diprivan
    • Updated labeling for RotaTeq
    • Vagisil Screening Kit for vaginal infections
    • Lexiva Oral Suspension approved for use in children
    • Neutrexin discontinued
    • Letairis approved for pulmonary arterial hypertension
    • Nuvigil approved for excessive sleepiness
    • Apidra approved for IV use
    • Peranex HC Cream available
    • Advancis Pharmaceutical now MiddleBrook Pharmaceuticals
    • Magnacet available for treating pain
    • Updated labeling for Actos
    • One month room temperature storage for Copaxone
    • Berry Burst! Metamucil available
    • Divigel available for treating hot flashes
    • Continuous 7-day Glucose Monitoring System approved
    • Fertell available for at-home testing
    • Norditropin for kids with Noonan syndrome
Simcor

FDA approves Simcor for cholesterol treatment

Date Posted: February 19, 2008

Abbott has received FDA approval for Simcor, a fixed-dose, single-pill combination of two cholesterol-lowering medications: Niaspan (niacin extended-release tablets) and simvastatin. Simcor is approved for use along with diet to lower levels of elevated total cholesterol, LDL cholesterol and triglycerides, and to raise HDL cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate. Simcor is expected to be available in March 2008.

For more information call (800) 633-9110 or visit www.abbott.com.

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