➡️Mulpleta (lusutrombopag) Tablets

Date of Approval: July 31, 2018
Company: Shionogi Inc.
Treatment for: Thrombocytopenia

Mulpleta (lusutrombopag) is a once-daily, orally administered, thrombopoietin (TPO) receptor agonist for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a medical or dental procedure.

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➡️Inveltys (loteprednol etabonate) Ophthalmic Suspension

Date of Approval: August 22, 2018
Company: Kala Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Inveltys (loteprednol etabonate) is a nanoparticle ocular corticosteroid formulation for the treatment of post-operative ocular inflammation and pain.


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➡️Altreno (tretinoin) Lotion

Date of Approval: August 23, 2018
Company: Ortho Dermatologics
Treatment for: Acne

Altreno (tretinoin) is a topical retinoid for the treatment of acne.

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➡️Xerava (eravacycline) Injection

Date of Approval: August 27, 2018
Company: Tetraphase Pharmaceuticals, Inc.
Treatment for: Complicated Intra-Abdominal Infections

Xerava (eravacycline) is a fluorocycline antibiotic indicated for the treatment of complicated intra-abdominal infections.

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➡️Jivi (antihemophilic factor [recombinant] PEGylated-aucl) Injection

Date of Approval: August 30, 2018
Company: Bayer HealthCare LLC
Treatment for: Hemophilia A

Jivi (antihemophilic factor (recombinant), PEGylated-aucl) is a recombinant DNA-derived, Factor VIII concentrate indicated to treat and control bleeding in patients with hemophilia A.

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➡️Lumoxiti (moxetumomab pasudotox-tdfk) Injection

Date of Approval: September 13, 2018
Company: AstraZeneca and MedImmune
Treatment for: Hairy Cell Leukemia

Lumoxiti (moxetumomab pasudotox-tdfk) is an anti-CD22 recombinant immunotoxin for the treatment of adult patients with hairy cell leukemia.


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➡️Arikayce (amikacin liposome) Inhalation Suspension

Date of Approval: September 28, 2018
Company: Insmed, Inc.
Treatment for: Mycobacterium Avium Complex (MAC) Lung Disease

Arikayce (amikacin liposome inhalation suspension) is an aminoglycoside antibacterial indicated for the treatment of Mycobacterium avium complex (MAC) lung disease in adults who have limited or no alternative treatment options.

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➡️Seysara (sarecycline) Tablets

Date of Approval: October 1, 2018
Company: Almirall, S.A.
Treatment for: Acne

Seysara (sarecycline) is an oral, narrow spectrum tetracycline-derived antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.

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➡️Nuzyra (omadacycline) Tablets and Lyophilized Powder for Injection

Date of Approval: October 2, 2018
Company: Paratek Pharmaceuticals, Inc.
Treatment for: Skin and Structure Infection, Pneumonia

Nuzyra (omadacycline) is an aminomethylcycline tetracycline antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)

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➡️Yutiq (fluocinolone acetonide) Intravitreal Implant

Date of Approval: October 12, 2018
Company: EyePoint Pharmaceuticals, Inc.
Treatment for: Non-Infectious Posterior Segment Uveitis

Yutiq (fluocinolone acetonide) is a corticosteroid intravitreal implant indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

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➡️Talzenna (talazoparib) Capsules

Date of Approval: October 16, 2018
Company: Pfizer Inc.
Treatment for: Breast Cancer

Talzenna (talazoparib) is an oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.

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➡️Xofluza (baloxavir marboxil) Tablets and Granules for Oral Suspension

Date of Approval: October 24, 2018
Company: Genentech, Inc.
Treatment for: Influenza

Xofluza (baloxavir marboxil) is a polymerase acidic (PA) endonuclease inhibitor for the treatment of influenza, and for the post-exposure prophylaxis of influenza in people 12 years of age and older.

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➡️Bijuva (estradiol and progesterone) Capsules - formerly TX-001HR

Date of Approval: October 28, 2018
Company: TherapeuticsMD, Inc.
Treatment for: Menopausal Vasomotor Symptoms

Bijuva (estradiol and progesterone) is a bio-identical hormone combination for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) due to menopause.

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➡️Dsuvia (sufentanil) Sublingual Tablets

Date of Approval: November 2, 2018
Company: AcelRx Pharmaceuticals, Inc.
Treatment for: Pain

Dsuvia (sufentanil) is a synthetic opioid analgesic formulation for the management of acute pain that is severe enough to require an opioid analgesic, and for which alternative treatments are inadequate.

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➡️Bryhali (halobetasol propionate) Lotion - formerly Jemdel

Date of Approval: November 6, 2018
Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Bryhali (halobetasol propionate) is a high-potency topical corticosteroid formulation for the treatment of plaque psoriasis in adults.

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➡️Yupelri (revefenacin) Inhalation Solution

Date of Approval: November 9, 2018
Company: Theravance Biopharma, Inc.
Treatment for: COPD

Yupelri (revefenacin) is a long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD).

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➡️Aemcolo (rifamycin) Delayed-Release Tablets

Date of Approval: November 16, 2018
Company: Cosmo Technologies, Ltd.
Treatment for: Traveler's Diarrhea

Aemcolo (rifamycin) is a broad spectrum, orally non-absorbable antibiotic for the treatment of traveler’s diarrhea caused by noninvasive strains of Escherichia coli.

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➡️Dextenza (dexamethasone) Ophthalmic Insert

Date of Approval: November 30, 2018
Company: Ocular Therapeutix, Inc.
Treatment for: Postoperative Ocular Inflammation, Conjunctivitis, Allergic

Dextenza (dexamethasone ophthalmic insert) is a corticosteroid intracanalicular insert for the treatment of post-surgical ocular inflammation and pain, and ocular itching associated with allergic conjunctivitis

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➡️Elepsia XR (levetiracetam) Extended-Release Tablets

Date of Approval: December 20, 2018
Company: Sun Pharma Global
Treatment for: Epilepsy

Elepsia XR (levetiracetam) is an extended-release formulation of the antiepileptic drug levetiracetam designed to reduce pill burden in patients receiving high doses for the treatment of partial onset seizures.


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➡️Tolsura (itraconazole) Capsules

Date of Approval: December 11, 2018
Company: Mayne Pharma
Treatment for: Blastomycosis; Histoplasmosis; Aspergillosis

Tolsura (itraconazole) is an azole antifungal indicated for the treatment of certain fungal infections including blastomycosis, histoplasmosis and aspergillosis.

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