Type | Drug (active ingredient)** | Year | ETASU*** | Indication (Benefit) | Risk(s) requiring Risk Mitigation | Number of Assessment Items |
---|---|---|---|---|---|---|
ANDA | Clozapine | 2015 | A, B, D, E, F | treatment-resistant schizophrenia; reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder | Neutropenia | 22 |
Alosetron | 2016 | A | severe diarrhea-prominent irritable bowel syndrome in women | Ischemic colitis and serious complications of constipation | 10 | |
Sodium Oxybate | 2017 | A, B, D (MG) | treatment of cataplexy or excessive daytime sleepiness in narcolepsy | Serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion | 71 | |
Vigabatrin | 2017 | A, B, D, E | treatment of refractory complex partial seizures in adults and infantile spasms | Vision loss | 23 | |
Emtricitabine/Tenofovir Disoproxil Fumarate | 2017 | A | treatment of HIV-1 infection | Acquiring HIV-1 infection | 8 | |
BLA | Myalept (metreleptin) | 2014 | A, B, D | treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy | Lymphoma & anti-metreleptin antibodies that neutralize endogenous leptin and/or Myalept | 26 |
Lemtrada (alemtuzumab) | 2014 | A, B, C, D (CP) | treatment of patients with relapsing forms of multiple sclerosis | Autoimmune conditions, infusion reactions, and malignancies | 36 | |
Natpara (parathyroid hormone) | 2015 | A, B, D | an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism | Osteosarcoma | 21 | |
Zinbryta (daclizumab) | 2017 | A, B, D, E, F (CP) | treatment of adult patients with relapsing forms of multiple sclerosis | Hepatic injury & immune mediated disorders | 27 | |
Siliq (brodalumab) | 2017 | A, B, D | treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies | Suicidal ideation and behavior, including completed suicides | 31 | |
Kymriah (tisagenlecleucel) | 2017 | B, C | treatment of: Pediatric and Young Adult Relapsed or Refractory (r/r) B-cell Acute Lymphoblastic Leukemia & Adult Relapsed or Refractory (r/r) Diffuse Large B-Cell Lymphoma | Cytokine release syndrome & neurological toxicities | 21 | |
Yescarta (axicabtagene ciloleucel) | 2017 | B, C | treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy | Cytokine release syndrome & neurological toxicities | 21 | |
Palynziq (pegvaliase-pqpz) | 2018 | A, B, D | reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management | Anaphylaxis | 31 | |
Ultomiris (ravulizumab-cwvz) | 2018 | A | treatment of adult patients with paroxysmal nocturnal hemoglobinuria | Meningococcal infections | 10 | |
NDA | Aveed (testosterone undecanoate) | 2014 | A, B, C | testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone | Autoimmune conditions, infusion reactions, and malignancies | 36 |
Xyrem (Sodium oxybate) | 2015 | A, B, D (MG) | treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy | Serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion | 57 | |
Ionsys (fentanyl iontophoretic) transdermal system) | 2015 | B, C | short-term management of acute postoperative pain severe enough to require an opioid analgesic in the hospital and for which alternative treatments are inadequate | Respiratory depression resulting from accidental exposure | 29 | |
Addyi (flibanserin) | 2015 | A, B | treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder, as characterized by low sexual desire that causes marked distress or interpersonal difficulty | Hypotension and syncope due to interaction with alcohol | 32 | |
Probuphine (buprenorphine hydrochloride) | 2016 | A, B, C, E (MG) | maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product | Migration, protrusion, expulsion and nerve damage associated with insertion and removal & accidental overdose, misuse and abuse | 22 | |
Sublocade (buprenorphine extended-release) | 2017 | B | treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days | Intravenous self-administration | 20 | |
Jynarque (tolvaptan) | 2018 | A, B, D, E, F (CP) | slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease | Liver injury | 42 | |
Tegsedi (Inotersen) | 2018 | A, B, D, E, F | treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults | Bleeding with thrombocytopenia & glomerulonephritis | 57 | |
Dsuvia (sufentanil) | 2018 | B, C | use in adults in certified medically supervised healthcare settings for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate | Respiratory depression from accidental exposure | 35 |