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I.

Priority Drugs
Orphan Approved PDUFA Approved Sponsor Drug first date on 1st in US met cycle Adcetris(brentuximab For treatment of X X X X Seattle Genetics vedotin) Hodgkin's lymphoma Bothell, WA and ALCL (systemic anaplastic large cell lymphoma). Anascorp(Centruroides For treatment of X X Rare Disease [Scorpion] Immune clinical signs of Therapeutics, F(ab)2 [Equine]) scorpion Inc., Franklin,TN envenomation. Benlysta(belimumab) To treat patients with X X X Human Genome active, autoantibodySciences, Inc., positive lupus Rockville, MD (systemic lupus co-marketed with erythematosus) who GlaxoSmithKline, are receiving Philadelphia, PA standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal antiinflammatory drugs. Caprelsa X X X X To treat adult AstraZeneca (vandetanib) patients with Pharmaceuticals metastatic (late-stage LP, Wilmington, ) medullary thyroid DE cancer who are ineligible for surgery and who have disease that is growing or causing symptoms. Corifact X X X For routine CSL Bhering (Factor XIII Concentrate prophylactic GmbH, [Human]) treatment of King of Prussia, congenital Factor XIII PA deficiency. DaTscan X For brain imaging to GE Healthcare, (ioflupane assist in the Inc., i-123) evaluation of adult Princeton, NJ patients with suspected Parkinsonian Syndrome. Dificid(fidaxomicin) X X X For treatment of Optimer Clostridium difficilePharmaceuticals associated diarrhea Inc., (CDAD). San Diego, CA Firazyr(icatibant) X X For treatment of Shire Human acute attacks of a Genetic rare condition called Therapies Inc., hereditary Cambridge, MA angioedema (HAE) in people ages 18 years and older. Halaven X X X For treatment of Eisai, Inc., (eribulin mesylate patients with Woodcliff Lake, metastatic (lateNJ stage) breast cancer Drug Name Indication

who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease Incivek(telaprevir) For treatment of certain adults with chronic hepatitis C infection. Pradaxa To reduce the risk of (dabigatran etexilate) stroke and blood clots in patients with abnormal heart rhythms (non-valvular atrial fibrillation). Victrelis(boceprevir) To treat certain adults with chronic hepatitis C infection. Xalkori(crizotinib) and To treat certain companion genetic test patients with late stage (locally advanced or metastatic), nonsmall cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. Yervoy(ipilimumab) To treat patients with metastatic melanoma (late-stage skin cancer). Zelboraf(vemuranfenib) To treat patients with with companion metastatic (latediagnostic stage) or unresected (cannot be removed by surgery) melanoma (skin cancer) in patients whose tumors express a gene mutation called BRAF V600E.

Vertex Pharmaceuticals, Cambridge, MA Boehringer Ingelheim Pharm, Inc, Ridgefield, CT Merck, Whitehouse Station, NJ Xalkori is marketed by Pfizer, New York, NY, and the Vysis ALK Break Apart FISH Probe Kit is marketed by Abbott Molecular Inc. of Des Plaines, IL. Bristol-Meyers Squibb, New York, NY Zelboraf is marketed by Genentech, a member of the Roche Group, South San Francisco, CA. The cobas 4800 BRAF V600 Mutation Test is manufactured by Roche Molecular Systems, Pleasanton, CA Centocor Ortho Biotech, Inc., Horsham, PA

Zytiga(albiraterone acetate)

To use In combination with prednisone (a steroid), to treat patients with metastatic (latestage) castrationresistant prostate cancer who have received prior docetaxel (chemotherapy).

II. Standard Drugs

Drug Name Arcapta Neohaler(indacaterol inhalation powder)

Ardovax(Adenovirus Type 4 and Type 7 Vaccine, Live, Oral)

Brilinta(ticagrelor)

Daliresp(roflumilast)

Edarbi(azilsartan medoxomil)

Edurant(rilpivirine)

Egrifta (tesamorelin acetate)

Gadavist (gadobutrol)

Horizant(gabapentin enacarbil)

Latuda (lurasidone hydrochloride)

For long term, oncedaily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. For active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is approved for use in military populations 17 through 50 years of age. To reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). To decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD). For treatment of high blood pressure (hypertension) in adults. For treatment of HIV-1 infection in adults who have never taken HIV therapy. For reduction of excess abdominal fat in HIVinfected patients with lipodystrophy. Contrast agent to help detect lesions in patients undergoing magnetic resonance imaging (MRI) of the central nervous system For once-daily treatment for moderate-to-severe restless legs syndrome (RLS). For treatment of schizophrenia in adults.

For improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. Natroba(spinosad) For treatment of head lice infestation in patients ages 4 years and older. Nulojix(belatacept) To prevent organ rejection in adult patients who have had a kidney transplant, in combination with other immunosuppressants. Potiga(ezogabine) For use as an add-on medication to treat seizures associated with epilepsy in adults. Spherusol(Coccidioides For detection of immitis Spheruledelayed type Derived Skin Test hypersensitivity to C. Antigen) immitis in individuals, 18-64 years of age, with a history of pulmonary coccidioidomycosis. Teflaro(ceftaroline For treatment of acute fosamil) bacterial skin and skin structure infections and community acquired bacterial pneumonia. Tradjenta(linagliptin) For use as an adjunct to diet and exercise to improve glycemic (blood sugar) control in adults with type 2 diabetes. Viibryd(vilazodone For treatment of major hydrochloride) depressive disorder in adults. Xarelto(rivaroxaban) To reduce the risk of blood clots, deep vein thrombosis(DVT), and pulmonary embolism (PE) following knee or hip replacement surgery.

LaViv (Azficel-T)

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