New Drugs of 2004 (Notes to Accompany Videos)

106 New Drug Applications Approved

31 New Molecular Entities

86 Standard Review

20 Priority Review

7 Orphan Drug Designation

Orphan Drug Act (1983)

Pain/Neuropathy: Cymbalta (duloxetine hydrochloride)

Major depression

Diabetic peripheral neuropathy

Lyrica (pregabalin)

Diabetic peripheral neuropathy

Postherpetic neuralgia pain (shingles)

Pain/Neuropathy: Prialt (ziconotide)

Severe refractory pain

Intrathecal infusion

Overactive Bladder: Enablex  (darifenacin)

Selective  muscarinic receptor antagonist

7.5  and 15 mg controlled-release tablets

VESIcare  (solifenacin succinate)

Competitive  muscarinic receptor antagonist

5  and 10 mg tablets

Overactive Bladder: Sanctura  (trospium chloride)

Antispasmodic  and antimuscarinic

20  mg coated tablet

Oncology Drugs: Vidaza  (azacitidine)

Myelodysplastic  syndrome

Subcutaneous  injection

Clolar  (clofarabine)

Relapsed/refractory  actue lymphoblastic leukemia

Antimetabolite

IV  infusion

Oncology Drugs

Tarceva  (erlotinib)

Locally  advanced or metastatic non-small cell lung cancer

25,  100 and 150 mg tablets

Alimta  (pemetrexed disodium)

Malignant  pleural mesothelioma

IV  infusion over 10 minutes on day 1 of each 21 day cycle

Diagnostic Aids: Chirhostim  (human secretin)

Stimulates  pancreatic secretions

Aid  in the diagnosis of pancreatic exocrine dysfunction and gastroinoma

For  use in endoscopic retrograde cholangiopancreatography (ERCP)

IV  injection

Diagnostic Aids: Multihance  (gadobenate dimeglumine)

IV  use in MRI of the CNS

Helps  visualize lesions

Alcohol Dependence: Campral (acamprosate calcium)

Maintenance of abstinence

666 mg tid with meals

333 mg delayed-release tablet

Parkinson’s: Apokyn (apomorphine hydrochloride)

Hypomobility with advanced Parkinson’s disease

10 mg/mL SQ injection

Dosed in mL – not mg

Hyperparathyroidism: Sensipar (cinacalcet hydrochloride)

Secondary hyperparathyroidism in patients with chronic  kidney disease

30 mg per day with food

30 mg oral tablet

Insomnia: Lunesta (eszopiclone)

Schedule IV

2-3 mg at night right before bedtime

1, 2 and 3 mg oral tablets

Pulmonary Drugs: Ventavis (iloprost)

Pulmonary arterial hypertension in patients with New  York Heart Association class II or IV symptoms

Inhalation

Diabetes: Apidra (insulin glulisine)

Rapid onset of action and short duration

Mealtime in conjunction with longer-acting or basal  insulin, or a sulfonylurea

End-Stage Renal Disease: Fosrenol (lanthanum carbonate)

Phosphate binder for patients with end-stage renal  disease

750 – 1500 mg with meals daily, divided

250 and 500 mg chewable tablets

Supplement: NutreStore (L-glutamine)

Amino acid supplement

Short bowel syndrome in conjunction with human growth  hormone treatment and specialized diet

Powder for oral suspension

30 grams per day in divided doses

Hyperlipidemia: Omacor (omega-3-acid ethyl esters)

Adjunct agent to diet in the  treatment of refractory very high TGs  (>500 mg/dL)

4 caps qd or 2 caps bid

1 gram soft-gelatin capsule

Macular Degeneration: Macugen (pegaptanib)

Antivascular endothelial growth factor therapy

Neovascular age-related macular degeneration (“wet”  AMD)

0.3 mg administered once q 6 weeks for intravitreous  injection into the eye

Diarrhea: Xifaxan (rifaximin)

Traveler’s diarrhea due to E. coli

200 mg tid with or without food

200 mg oral tablet

Anti-infectives: Ketek (telithromycin)

Chronic bronchitis

Sinusitis

Community-acquired pneumonia

800 mg once a day for 5 -10 days

400 mg tablet

Anti-infectives: Tindamax (tinidazole)

Trichomoniasis 

Giardiasis

Intestinal amebiasis

Second generation nitroimidazole

Dose depends on diagnosis

COPD: Spiriva Handihaler (tiotropium bromide)

Chronic obstructive pulmonary disease

Once daily, long-term maintenance

18 mcg per capsule

Misc. Drugs: VisionBlue (trypan blue)

Tissue-staining agent for ophthalmic surgery

Pentetate Calcium Trisodium

Pentetate Zinc Trisodium

Internal contamination of plutonium, americium, and  curium

Misc. Drugs: Amphadase (hyaluronidase)

Vitrase (ovine hyaluronidase)

Adjunct to increase absorption and dispersion of other  injected drugs

Biologics: Avastin (bevacizumab)

Metastatic colorectal carcinoma

Erbitux (cetuximab)

Epidermal growth factor receptor (EGFR)-expressing  metastatic colorectal cancer

Biologics: Raptiva (efalizumab)

Chronic moderate or severe plaque psoriasis

Subcutaneous injection

Kepivance (palifermin)

Decrease the incidence and duration of severe oral  mucositis

Biologics: Tysabri (natalizumab)

Relapsing multiple sclerosis

IV infusion every 4 weeks

Infuse over 1 hour