➡️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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➡️Motegrity (prucalopride) Tablets

Date of Approval: December 14, 2018
Company: Shire plc
Treatment for: Chronic Idiopathic Constipation

Motegrity (prucalopride) is a selective serotonin type 4 (5‑HT4) receptor agonist for the treatment of chronic idiopathic constipation (CIC) in adults.

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➡️Inbrija (levodopa) Inhalation Powder

Date of Approval: December 21, 2018
Company: Acorda Therapeutics, Inc.
Treatment for: Parkinson's Disease

Inbrija (levodopa) is an oral inhalation formulation of the approved drug levodopa for the treatment of OFF episodes in people with Parkinson’s disease taking a carbidopa/levodopa regimen.


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➡️ProAir Digihaler (albuterol sulfate) Inhalation Powder

Date of Approval: December 21, 2018
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Bronchospasm Prophylaxis, Asthma, COPD

ProAir Digihaler (albuterol sulfate) is a beta2-adrenergic agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, and the prevention of exercise-induced bronchospasm.

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➡️Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) Suspension for Intramuscular Injection

Date of Approval: December 21, 2018
Company: Merck and Sanofi
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis, Poliomyelitis Prophylaxis, Hepatitis B Prevention, Haemophilus influenzae Prophylaxis

Vaxelis is a hexavalent combination vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b in children from 6 weeks through 4 years of age (prior to the 5th birthday).

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➡️Rhofade (oxymetazoline hydrochloride) Cream

Date of Approval: January 18, 2017
Company: Allergan plc
Treatment for: Rosacea

Rhofade (oxymetazoline hydrochloride) is a topical alpha1A adrenoceptor agonist vasoconstrictor for the treatment of persistent facial erythema associated with rosacea in adults.

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➡️AirDuo RespiClick (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: January 27, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma, Maintenance

AirDuo RespiClick (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

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➡️ArmonAir RespiClick (fluticasone propionate) Inhalation Powder

Date of Approval: January 27, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma, Maintenance

ArmonAir RespiClick (fluticasone propionate) is an inhaled corticosteroid in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

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