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Drug News

July 2, 2008
  • Anthelios 40 sunscreen now available
  • Zingo now available for topical analgesia
July 1, 2008
  • Aciphex approved for adolescent GERD
  • FDA approves Evolence as facial dermal filler
  • Generic Risperdal launched
  • ► June 2008
    • Generic Marinol launched
    • OTC Refresh Eye Itch Relief launched
    • Concerta approved for adult ADHD
    • Aptivus oral solution approved for HIV
    • Durezol approved for eye surgery recovery
    • Kinrix pediatric vaccine approved
    • Lexiscan launched for stress testing
    • PrandiMet approved for diabetes
    • Pentacel pediatric vaccine approved
    • Velcade approved for untreated multiple myeloma
    • Avodart combination approved for symptomatic BPH
    • Arkray launches Glucocard X-Meter monitor
    • Conventional antipsychotics get boxed warning
    • Spectrum to launch Fusilev injection
    • Trivaris approved for ocular inflammation
    • Ethex recalls additional morphine tablets
    • FDA approves Cymbalta for fibromyalgia
    • Requip XL approved for Parkinson’s
    • Ethex recalls morphine tablets
    • Cancer warning for Regranex
    • Entereg launched for GI surgical recovery
    • Shire recalls Daytrana patches
    • King discontinues Cortisporin otic suspension
    • Cortisporin ophthalmic suspension discontinued
    • FDA investigates pediatric cancer risk with TNF-blockers
    • King discontinues Kemadrin tablets
    • Reclast approved for fracture prevention
    • King discontinues Intal nebulizer solution
    • CFC-propelled inhalers to be discontinued
    ► May 2008
    • FDA approves two breast cancer regimens
    • FDA proposes revisions to pregnancy and breastfeeding drug labeling
    • Amitiza 8mcg capsules available
    • Additional Recothrom vial size approved
    • Barrier Therapeutics to launch Xolegel Duo
    • Generic Sarafem available
    • Entereg approved for GI surgical recovery
    • Ferralet 90 available for anemia treatment
    • Medicis recalls Solodyn
    • Additional Prezista tablet strength available
    • FDA issues CellCept and Myfortic pregnancy alert
    • Reformulated Leukine now available
    • CDC recommends shingle vaccination for elderly
    • Trasylol withdrawn from market
    • FDA approves Seroquel for bipolar maintenance
    • Generic Paxil CR launched
    • FDA approves Taclonex Scalp for psoriasis
    • Generic Yasmin approved
    • NovoSeven RT approved to control surgical bleeding
    • » OraVerse approved for dental anesthetic recovery
    • Abilify gains expanded bipolar and schizophrenia indications
    • FDA approves Strattera for ADHD maintenance
    • Generic Dovonex scalp solution launched
    • King discontinues Tilade Inhaler
    • Metamucil Pink Lemonade available
    • 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

OraVerse approved for dental anesthetic recovery

Date Posted: May 12, 2008

Novalar has received approval to market OraVerse (phentolamine mesylate injection) for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic. In clinical trials, OraVerse reduced the median recovery time to normal sensation in the lower lip by 85 minutes and in the upper lip by 83 minutes compared to control. Within one hour after OraVerse administration, 41% of patients reported normal lower lip sensation as compared to 7% in the control group, and 59% of patients in the OraVerse group reported normal upper lip sensation as compared to 12% in the control group.

OraVerse is expected to launch in October 2008.

For more information call (858) 436-1100 or visit www.novalarpharm.com.

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