New Drug Product Slideshows

Glyxambi

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

Lenvima

Treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

Savaysa

To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with parenteral anticoagulant.

Belsomra

Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Rapivab

Treatment of acute uncomplicated influenza in patients who have been symptomatic for ≤2 days.

Blincyto

Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Viekira Pak

Chronic hepatitis C virus (HCV) genotype 1 infection, with or without ribavirin, including those with compensated cirrhosis.

Xigduo XR

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ­dapagliflozin and metformin is appropriate.

New Products

GLYXAMBI

GLYXAMBI

  • 4/19/2015
  • Boehringer Ingelheim and Lilly
  • Empagliflozin, linagliptin; 10mg/5mg, 25mg/5mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis. Not studied in patients with a history of pancreatitis.
LENVIMA

LENVIMA

  • 4/12/2015
  • Eisai Pharmaceuticals
  • Lenvatinib 4mg, 10mg; capsules.
  • Treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

SAVAYSA

  • 4/5/2015
  • Daiichi Sankyo
  • Edoxaban 15mg, 30mg, 60mg; tablets.
  • To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with parenteral anticoagulant. Limitations of use: not for use in NVAF patients with CrCl >95mL/min.
BELSOMRA

BELSOMRA

  • 3/29/2015
  • Merck Co., Inc.
  • Suvorexant 5mg, 10mg, 15mg, 20mg; tablets.
  • Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
RAPIVAB

RAPIVAB

  • 3/22/2015
  • BioCryst Pharmaceuticals, Inc.
  • Peramivir 10mg/mL; per vial; solution for IV injection after dilution; preservative-free.
  • Treatment of acute uncomplicated influenza in patients who have been symptomatic for ≤2 days. Limitations of use: Efficacy based on predominantly influenza A virus infections; limited number of influenza B virus subjects enrolled. Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. Efficacy not established in serious influenza requiring hospitalization.
BLINCYTO

BLINCYTO

  • 3/15/2015
  • Amgen, Inc.
  • Blinatumomab 35mcg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
  • Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
VIEKIRA PAK

VIEKIRA PAK

  • 3/8/2015
  • AbbVie
  • Ombitasvir/paritaprevir/ritonavir; 12.5mg/75mg/50mg; with dasabuvir 250mg; tablets.
  • Chronic hepatitis C virus (HCV) genotype 1 infection, with or without ribavirin, including those with compensated cirrhosis. Limitations of use: not for use in patients with decompensated liver disease.
XIGDUO XR

XIGDUO XR

  • 3/1/2015
  • AstraZeneca Pharmaceuticals
  • Dapagliflozin, metformin HCl ext-rel; 5mg/500mg, 5mg/1000mg, 10mg/500mg, 10mg/1000mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ­dapagliflozin and metformin is appropriate. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis.
AKYNZEO

AKYNZEO

  • 2/22/2015
  • Eisai Pharmaceuticals
  • Netupitant, palonosetron (as HCl) 300mg/0.5mg; hard gelatin capsules.
  • Prevention of acute and delayed nausea and vomiting due to initial and repeat courses of chemotherapy, including highly emetogenic chemotherapy.
LYNPARZA

LYNPARZA

  • 2/15/2015
  • AstraZeneca Pharmaceuticals
  • Olaparib 50mg; capsules.
  • Monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with ≥3 prior lines of chemotherapy.
HARVONI

HARVONI

  • 2/8/2015
  • Gilead Sciences, Inc.
  • Ledipasvir, sofosbuvir 90mg/400mg; tablets.
  • Chronic hepatitis C (CHC) genotype 1 infection.
HYSINGLA ER

HYSINGLA ER

  • 2/1/2015
  • Purdue Pharma L.P.
  • Hydrocodone bitartrate 20mg, 30mg, 40mg, 60mg, 80mg, 100mg, 120mg; extended release tablets.
  • Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of use: reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or inadequate to manage pain. Not indicated as an as-needed (prn) analgesic.
DUOPA

DUOPA

  • 1/25/2015
  • AbbVie
  • Carbidopa 4.63mg (as 5mg of monohydrate), levodopa 20mg; per mL; enteral susp; use with CADD-Legacy 1400 pump.
  • Treatment of motor fluctuations in advanced Parkinson’s disease.
OFEV

OFEV

ESBRIET

ESBRIET

  • 1/11/2015
  • InterMune
  • Pirfenidone 267mg; hard gelatin capsules.
  • Treatment of idiopathic pulmonary fibrosis (IPF).
KEYTRUDA

KEYTRUDA

  • 12/14/2014
  • Merck Co., Inc.
  • Pembrolizumab 50mg; per vial; lyophilized powder for IV infusion after reconstitution; preservative-free.
  • Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
CONTRAVE

CONTRAVE

  • 12/7/2014
  • Takeda Pharmaceuticals North America, Inc.
  • Naltrexone HCl, bupropion HCl 8mg/90mg; extended-release tablets.
  • Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight-related comorbidity (eg, hypertension, type 2 diabetes, or dyslipidemia). Limitations of use: effect on cardiovascular morbidity and mortality has not been established. Safety and efficacy in combination with other weight loss products, including Rx or OTC drugs, and herbal preps, have not been established.
TRIUMEQ

TRIUMEQ

  • 11/30/2014
  • ViiV Healthcare
  • Abacavir 600mg, dolutegravir 50mg, lamivudine 300mg; tablets.
  • HIV-1 infection. Limitations of use: not recommended alone in patients with current or history of resistance to any of the components; or alone in resistance-associated integrase substitutions or INSTI resistance due to insufficient dolutegravir dose in Triumeq in these subpopulations.
TRULICITY

TRULICITY

  • 11/23/2014
  • Lilly, Eli and Company
  • Dulaglutide 0.75mg/0.5mL, 1.5mg/0.5mL; solution for SC injection; pen or prefilled syringe.
  • Adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes. Limitations of use: not recommended as first-line treatment for patients inadequately controlled on diet and exercise. Not studied in combination with basal insulin or with history of pancreatitis. Not for treating type 1 diabetes or diabetic ketoacidosis. Not a substitute for insulin. Not recommended in patients with pre-existing severe GI disease.
ORBACTIV

ORBACTIV

  • 11/14/2014
  • The Medicines Company
  • Oritavancin 400mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free.
  • Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible Gram (+) microorganisms: Staphylococcus aureus (including MRSA and MSSA), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin-susceptible isolates only).