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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

Aemcolo (rifamycin)

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

Aemcolo (rifamycin) is a broad spectrum, orally non-absorbable antibiotic for the treatment of traveler’s diarrhea.

Yupelri (revefenacin) Inhalation Solution

Company: Theravance, Inc.
Date of Approval: November 9, 2018
Treatment for: Chronic Obstructive Pulmonary Disease

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

Primatene Mist (epinephrine) Inhalation Aerosol

Company: Amphastar Pharmaceuticals, Inc.
Date of Approval: November 8, 2018
Treatment for: Asthma

Primatene Mist (epinephrine) is an over-the-counter (OTC) bronchodilator used for the temporary relief of the symptoms of mild asthma. The new formulation of Primatene Mist approved November 2018 is a CFC-free metered dose inhaler (MDI) containing hydrofluoroalkane (HFA) propellants.

Bryhali (halobetasol propionate) Lotion - formerly Jemdel

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

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

Lorbrena (lorlatinib) Tablets

Company: Pfizer Inc.
Date of Approval: November 2, 2018
Treatment for: Non-Small Cell Lung Cancer

Lorbrena (lorlatinib) is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC).

Udenyca (pegfilgrastim-cbqv) Injection

Company: Coherus BioSciences, Inc.
Date of Approval: November 2, 2018

Udenyca (pegfilgrastim-cbqv) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy.

Dsuvia (sufentanil) Sublingual Tablets

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

Sympazan (clobazam) Oral Film

Company: Aquestive Therapeutics, Inc.
Date of Approval: November 1, 2018
Treatment for: Lennox-Gastaut Syndrome

Sympazan (clobazam) is an oral film benzodiazepine formulation indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.

Hyrimoz (adalimumab-adaz) Injection

Company: Sandoz Inc.
Date of Approval: October 30, 2018
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease -- Maintenance, Ulcerative Colitis, Plaque Psoriasis

Hyrimoz (adalimumab-adaz) is an anti-TNF-α monoclonal antibody biosimilar to Humira, approved for the treatment of various inflammatory diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

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

Company: TherapeuticsMD, Inc.
Date of Approval: October 28, 2018
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.

Xofluza (baloxavir marboxil) Tablets

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

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

Khapzory (levoleucovorin) for Injection

Company: Spectrum Pharmaceuticals, Inc.
Date of Approval: October 19, 2018
Treatment for: Methotrexate Rescue, Folic Acid Antagonist Overdose, Colorectal Cancer

Khapzory (levoleucovorin) is a folate analog indicated for:

  • rescue after high-dose methotrexate therapy in patients with osteosarcoma
  • diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination
  • treatment of patients with metastatic colorectal cancer in combination with fluorouracil.

Talzenna (talazoparib) Capsules

Company: Pfizer Inc.
Date of Approval: October 16, 2018
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.

Yutiq (fluocinolone acetonide) Intravitreal Implant

Company: EyePoint Pharmaceuticals, Inc.
Date of Approval: October 12, 2018
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.

Tegsedi (inotersen) Injection

Company: Ionis Pharmaceuticals, Inc.
Date of Approval: October 5, 2018
Treatment for: Amyloidogenic Transthyretin Amyloidosis

Tegsedi (inotersen) is an antisense oligonucleotide inhibitor of the transthyretin (TTR) protein for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Revcovi (elapegademase-lvlr) Injection

Company: Leadiant Biosciences, Inc.
Date of Approval: October 5, 2018
Treatment for: Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)

Revcovi (elapegademase-lvlr) is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID).

Nuzyra (omadacycline) for Injection and Tablets

Company: Paratek Pharmaceuticals, Inc.
Date of Approval: October 2, 2018
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).

Seysara (sarecycline) Tablets

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

Xyosted (testosterone enanthate) Subcutaneous Injection

Company: Antares Pharma, Inc.
Date of Approval: September 28, 2018
Treatment for: Hypogonadism -- Male

Xyosted (testosterone enanthate) is a self-administered, subcutaneous injection formulation of the androgen testosterone for the treatment of male hypogonadism, also known as testosterone deficiency or Low T.

Libtayo (cemiplimab-rwlc) Injection

Company: Sanofi
Date of Approval: September 28, 2018
Treatment for: Squamous Cell Carcinoma

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC).

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