New Indications & Dosage Forms for Existing Drugs

Xtandi (enzalutamide) Capsules

Xtandi (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer.

Date of Original Approval: August 31, 2012 (Xtandi approval history)

• FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

Opdivo (nivolumab) Injection

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

Date of Original Approval: December 22, 2014 (Opdivo approval history)

• Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Combination Approved for Previously Treated MSI-H/dMMR Metastatic Colorectal Cancer

Xeomin (incobotulinumtoxinA) Injection

Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of cervical dystonia, blepharospasm, glabellar lines, upper limb spasticity, and excessive drooling.

Date of Original Approval: July 30, 2010 (Xeomin approval history)

• FDA Approves Xeomin (incobotulinumtoxinA) for Adult Patients with Sialorrhea (Excessive Drooling)

Nuplazid (pimavanserin) Tablets and Capsules

Nuplazid (pimavanserin) is a non-dopaminergic, selective serotonin inverse agonist (SSIA) for the treatment of psychosis associated with Parkinson’s disease.

Date of Original Approval: April 29, 2016 (Nuplazid approval history)

• Acadia Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for Nuplazid (pimavanserin)

Aristada (aripiprazole lauroxil) Injection

Aristada (aripiprazole lauroxil) is an extended-release injectable atypical antipsychotic with one-month, six-week, and two-month dosing options for the treatment of schizophrenia.

Date of Original Approval: October 5, 2015 (Aristada approval history)

• FDA Approves Aristada Initio (aripiprazole lauroxil) for the Initiation of Aristada for Schizophrenia

Avastin (bevacizumab) Injection

Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody for the treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, fallopian tube cancer, and peritoneal cancer.

Date of Original Approval: February 26, 2004 (Avastin approval history)

• FDA Approves Genentech’s Avastin (bevacizumab) Plus Chemotherapy as a Treatment for Women With Advanced Ovarian Cancer Following Initial Surgery

Keytruda (pembrolizumab) for Injection

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, and primary mediastinal large B-cell lymphoma.

Date of Original Approval: September 4, 2014 (Keytruda approval history)

• FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

Keytruda (pembrolizumab) for Injection

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, and primary mediastinal large B-cell lymphoma.

Date of Original Approval: September 4, 2014 (Keytruda approval history)

• FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1

Venclexta (venetoclax) Tablets

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion.

Date of Original Approval: April 11, 2016 (Venclexta approval history)

• Genentech Announces FDA Approval for Venclexta Plus Rituxan for People With Previously Treated Chronic Lymphocytic Leukemia

Rituxan (rituximab) Injection for Intravenous Use

Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener's granulomatosus, microscopic polyangiitis, and pemphigus vulgaris.

Date of Original Approval: November 26, 1997

• FDA Approves Genentech’s Rituxan (rituximab) for Pemphigus Vulgaris

Mircera (epoetin beta-methoxy polyethylene glycol) Injection

Mircera (epoetin beta-methoxy polyethylene glycol) is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic renal failure.

Date of Original Approval: November 14, 2007 (Mircera approval history)

• FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis

Xeljanz (tofacitinib) Tablets

Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and moderately to severely active ulcerative colitis.

Date of Original Approval: November 6, 2012 (Xeljanz approval history)

• Pfizer Announces U.S. FDA Approves Xeljanz (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis

Cimzia (certolizumab pegol) Injection

Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Date of Original Approval: April 22, 2008 (Cimzia approval history)

• UCB Announces the Approval of Cimzia (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis

Prolia (denosumab) Injection

Prolia is a RANK ligand (RANKL) inhibitor indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, for the treatment of bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy, as a treatment to increase bone mass in men with osteoporosis at high risk for fracture, and for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture.

Date of Original Approval: June 1, 2010 (Prolia approval history)

• FDA Approves Prolia (denosumab) for Glucocorticoid-Induced Osteoporosis

Arnuity Ellipta (fluticasone furoate) Inhalation Powder

Arnuity Ellipta (fluticasone furoate inhalation powder) is a once-daily inhaled corticosteroid for the maintenance treatment of asthma.

Date of Original Approval: August 20, 2014 (Arnuity Ellipta approval history)

• GSK Receives FDA Approval of Arnuity Ellipta for Asthma in Children From 5 Years of Age

Taltz (ixekizumab) Injection

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of plaque psoriasis and psoriatic arthritis.

Date of Original Approval: March 22, 2016 (Taltz approval history)

• Lilly's Taltz (ixekizumab) Receives the First U.S. FDA Approval for Label Update to Include Data for Psoriasis Involving the Genital Area

Truvada (emtricitabine and tenofovir) Tablets

Truvada (emtricitabine and tenofovir disoproxil fumarate) is a combination of nucleoside analog HIV-1 reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, and for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in people at high risk.

Date of Original Approval: August 2, 2004 (Truvada approval history)

• FDA Approves Expanded Indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents

Gilenya (fingolimod) Capsules

Gilenya (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Date of Original Approval: September 21, 2010 (Gilenya approval history)

• FDA Expands Approval of Gilenya (fingolimod) to Treat Multiple Sclerosis in Pediatric Patients

Actemra (tocilizumab) Injection

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment rheumatoid arthritis; systemic juvenile idiopathic arthritis (SJIA); polyarticular juvenile idiopathic arthritis (PJIA); giant cell arteritis; and CAR T cell-induced severe or life-threatening cytokine release syndrome.

Date of Original Approval: January 8, 2010 (Actemra approval history)

• FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis

Briviact (brivaracetam)

Briviact (brivaracetam) is a selective, high-affinity synaptic vesicle protein 2A ligand and analog of levetiracetam indicated for the treatment of partial-onset seizures in patients with epilepsy.

Date of Original Approval: February 19, 2016 (Briviact approval history)

• UCB Announces Briviact (brivaracetam) Now Approved by FDA to Treat Partial-Onset (Focal) Seizures in Pediatric Epilepsy Patients

Darzalex (daratumumab) Injection

Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.

Date of Original Approval: November 16, 2015 (Darzalex approval history)

• Janssen Announces Darzalex (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible

Tafinlar (dabrafenib) Capsules

Tafinlar (dabrafenib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

Tafinlar is also indicated, in combination with trametinib (Mekinist), for:

• the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
• the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
• the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
• the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Date of Original Approval: May 29, 2013 (Tafinlar approval history)

• FDA Approves Tafinlar + Mekinist for the Treatment of BRAF-Positive Anaplastic Thyroid Cancer

Kymriah (tisagenlecleucel) Suspension for Intravenous Infusion

Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for use in patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and patients with relapsed or refractory (r/r) large B-cell lymphoma.

Date of Original Approval: August 30, 2017 (Kymriah approval history)

• Kymriah (tisagenlecleucel) Receives Second FDA Approval to Treat Appropriate Patients with Large B-Cell Lymphoma

Tafinlar (dabrafenib) Capsules

Tafinlar (dabrafenib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

Tafinlar is also indicated, in combination with trametinib (Mekinist), for:

• the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
• the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
• the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
• the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Date of Original Approval: May 29, 2013 (Tafinlar approval history)

• Novartis Receives FDA Approval of Tafinlar + Mekinist for Adjuvant Treatment of BRAF V600-Mutant Melanoma

Myrbetriq (mirabegron) Extended Release Tablets

Myrbetriq (mirabegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Date of Original Approval: June 28, 2012 (Myrbetriq approval history)

• FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with Solifenacin Succinate for the Treatment of Overactive Bladder Symptoms

Tagrisso (osimertinib) Tablets

Tagrisso (osimertinib) is a tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR) indicated for the treatment of patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer.

Date of Original Approval: November 13, 2015 (Tagrisso approval history)

• FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer

Opdivo (nivolumab) Injection

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

Date of Original Approval: December 22, 2014 (Opdivo approval history)

• FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma

Vonvendi (von willebrand factor (recombinant)) for Injection

Vonvendi [von Willebrand factor (recombinant)] is a recombinant von Willebrand factor (VWF) indicated for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease.

Date of Original Approval: December 8, 2015 (Vonvendi approval history)

• FDA Approves Vonvendi [von Willebrand factor (recombinant)] for Perioperative Management of Bleeding in Adult Patients with von Willebrand Disease

Praxbind (idarucizumab) Injection

Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) indicated as a specific reversal agent for the anticoagulant effect of dabigatran (Pradaxa).

Date of Original Approval: October 16, 2015 (Praxbind approval history)

• FDA Provides Full Approval to Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa

Afinitor (everolimus) Tablets

Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced HR+, HER2- breast cancer; progressive neuroendocrine tumors of pancreatic origin (PNET); progressive neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin; advanced renal cell carcinoma; and subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis.

Date of Original Approval: March 30, 2009 (Afinitor approval history)

• FDA Approves Afinitor Disperz (everolimus) for Tuberous Sclerosis Complex-Associated Partial-Onset Seizures

Rubraca (rucaparib) Tablets

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies; and for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Date of Original Approval: December 19, 2016 (Rubraca approval history)

• Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer

Exparel (bupivacaine liposome) Injectable Suspension

Exparel (bupivacaine liposome injectable suspension) is a long-acting non-opioid local analgesic for postsurgical local analgesia, and for use as a nerve block (interscalene brachial plexus block) to provide pain relief following shoulder surgeries.

Date of Original Approval: October 28, 2011 (Exparel approval history)

• Pacira Announces FDA Approval of Exparel as a Nerve Block to Produce Regional Analgesia

Bydureon (exenatide) Extended-Release Injectable Suspension

Bydureon (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in patients with type 2 diabetes.

Date of Original Approval: January 27, 2012 (Bydureon approval history)

• FDA Approves Bydureon (exenatide extended-release) for Use with Basal Insulin in Patients with Type 2 Diabetes with Inadequate Glycemic Control

Blincyto (blinatumomab) Injection

Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and minimal residual disease (MRD)-positive B-cell precursor ALL.

Date of Original Approval: December 3, 2014 (Blincyto approval history)

• FDA Expands Approval of Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia

Toujeo SoloStar (insulin glargine [rDNA origin]) Injection

Toujeo SoloStar (insulin glargine [rDNA origin] is a once-daily long-acting basal insulin used to improve glycemic control in adults with type 1 and type 2 diabetes.

Date of Original Approval: February 25, 2015 (Toujeo SoloStar approval history)

• FDA Approves Toujeo (insulin glargine) Max SoloStar

Tasigna (nilotinib) Capsules

Tasigna (nilotinib) is a kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML).

Date of Original Approval: October 29, 2007 (Tasigna approval history)

• Novartis Drug Tasigna Approved by FDA to Treat Children with Rare Form of Leukemia

Adcetris (brentuximab vedotin) Injection

Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) indicated for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.

Date of Original Approval: August 19, 2011 (Adcetris approval history)

• FDA Expands Approval of Adcetris (brentuximab vedotin) for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination with Chemotherapy

Lucentis (ranibizumab) Injection

Lucentis (ranibizumab) is a humanized anti-VEGF antibody fragment indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

Date of Original Approval: June 30, 2006 (Lucentis approval history)

• FDA Approves Genentech’s Lucentis (ranibizumab injection) 0.3 mg Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy

Hizentra (immune globulin subcutaneous (human)) Liquid

Hizentra (immune globulin subcutaneous (human)) is an immune globulin indicated for the treatment of primary immunodeficiency, and for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

Date of Original Approval: March 4, 2010 (Hizentra approval history)

• FDA Approves Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Opdivo (nivolumab) Injection

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

Date of Original Approval: December 22, 2014 (Opdivo approval history)

• Bristol-Myers Squibb’s Opdivo (nivolumab) Now the First and Only FDA-Approved PD-1 Inhibitor to Offer Every Four-Week Dosing

Latuda (lurasidone) Tablets

Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia and bipolar depression.

Date of Original Approval: October 28, 2010 (Latuda approval history)

• FDA Approves Latuda (lurasidone HCl) for Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)

Otiprio (ciprofloxacin) Otic Suspension

Otiprio (ciprofloxacin otic suspension) is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery, and for the treatment of acute otitis externa due to Pseudomonas aeruginosa and Staphylococcus aureus.

Date of Original Approval: December 10, 2015 (Otiprio approval history)

• Otonomy Announces FDA Approval of Otiprio (ciprofloxacin otic suspension) for Acute Otitis Externa

Verzenio (abemaciclib) Tablets

Verzenio (abemaciclib) is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Date of Original Approval: September 28, 2017 (Verzenio approval history)

• Lilly Receives Additional FDA Approval for Verzenio (abemaciclib), as Initial Treatment for Advanced Breast Cancer

Luzu (luliconazole) Topical Cream

Luzu (luliconazole) Cream is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis.

Date of Original Approval: November 14, 2013 (Luzu approval history)

• FDA Approves Expanded Use of Luzu (luliconazole) Cream in Pediatric Patients with Athlete’s Foot, Jock Itch and Ringworm

Imfinzi (durvalumab) Injection

Imfinzi (durvalumab) is an anti-PD-L1 (programmed death ligand-1) human monoclonal antibody for the treatment of patients with metastatic urothelial carcinoma and for the treatment of patients with unresectable non-small cell lung cancer that has not progressed after chemoradiation.

Date of Original Approval: May 1, 2017 (Imfinzi approval history)

• FDA Approves Imfinzi (durvalumab) for Unresectable Stage III Non-Small Cell Lung Cancer

Makena (hydroxyprogesterone caproate) Injection

Makena (hydroxyprogesterone caproate) is a long acting form of natural progesterone for the prevention of preterm birth in pregnant women.

Date of Original Approval: February 3, 2011 (Makena approval history)

• AMAG Pharmaceuticals Announces FDA Approval of Makena (hydroxyprogesterone caproate injection) Subcutaneous Auto-Injector to Reduce the Risk of Preterm Birth in Certain At-Risk Women

Zytiga (abiraterone) Tablets

Zytiga (abiraterone acetate) is a CYP17 inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.

Date of Original Approval: April 28, 2011 (Zytiga approval history)

• Zytiga (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer

Feraheme (ferumoxytol) Intravenous Injection

Feraheme (ferumoxytol) is an iron replacement therapy for the treatment of iron deficiency anemia in adult patients.

Date of Original Approval: June 30, 2009 (Feraheme approval history)

• AMAG Pharmaceuticals Announces FDA Approval of Feraheme (ferumoxytol injection) for All Eligible Adult Patients with Iron Deficiency Anemia

Avycaz (avibactam and ceftazidime) Injection

Avycaz (avibactam and ceftazidime) is a next generation, non-β lactam β-lactamase inhibitor and third-generation, antipseudomonal cephalosporin antibiotic combination for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia.

Date of Original Approval: February 25, 2015 (Avycaz approval history)

• FDA Approves Avycaz (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

Trulance (plecanatide) Tablets

Trulance (plecanatide) is a guanylate cyclase-C agonist for the treatment of chronic idiopathic constipation, and irritable bowel syndrome with constipation (IBS-C).

Date of Original Approval: January 19, 2017 (Trulance approval history)

• Synergy Pharmaceuticals Announces FDA Approval of Trulance (plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults