New Drug Product Slideshows

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.

Akynzeo

Prevention of acute and delayed nausea and vomiting due to initial and repeat courses of chemotherapy, including highly emetogenic chemotherapy.

Lynparza

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

Treatment of chronic hepatitis C (CHC) genotype 1 infection.

Hysingla ER

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Duopa

Treatment of motor fluctuations in advanced Parkinson’s disease.

Ofev

Treatment of idiopathic pulmonary fibrosis (IPF).

Esbriet

Treatment of idiopathic pulmonary fibrosis (IPF).

New Products

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).
ZYDELIG

ZYDELIG

  • 11/9/2014
  • Gilead Sciences, Inc.
  • Idelalisib 100mg, 150mg; tablets.
  • Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate due to other co-morbidities. Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least 2 prior systemic therapies. Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least 2 prior systemic therapies.
CERDELGA

CERDELGA

  • 11/2/2014
  • Genzyme Corporation
  • Eliglustat 84mg; hard-gelatin caps.
  • Long-term treatment of adults with Gaucher disease type 1 who are CYP2D6 extensive, intermediate, or poor metabolizers as detected by an FDA-cleared test. Limitations of use: CYP2D6 ultra-rapid metabolizers may not achieve adequate concentrations for a therapeutic effect. No dosage recommendation for CYP2D6 indeterminate metabolizers.
CYRAMZA

CYRAMZA

  • 10/26/2014
  • Lilly, Eli and Company
  • Ramucirumab 10mg/mL; per vial; solution for IV infusion after dilution; preservative-free.
  • Treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
STRIVERDI RESPIMAT

STRIVERDI RESPIMAT

  • 10/19/2014
  • Boehringer Ingelheim Pharmaceuticals
  • Olodaterol 2.5mcg; per actuation; inhalation spray; contains benzalkonium chloride.
  • Long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Limitations of use: not for treating asthma or acute deteriorations of COPD.

NORTHERA

  • 10/12/2014
  • Lundbeck Inc.
  • Droxidopa 100mg, 200mg, 300mg+; capsules; (+) contains tartrazine.
  • Orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adults with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.
KERYDIN

KERYDIN

  • 10/5/2014
  • Sandoz
  • Tavaborole 5%; topical soln; contains alcohol.
  • Treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
JARDIANCE

JARDIANCE

  • 9/28/2014
  • Boehringer Ingelheim and Lilly
  • Empagliflozin 10mg, 25mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis.