New Drug Approvals

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.

• FDA Approves Aemcolo (rifamycin) to Treat Travelers’ Diarrhea - November 16, 2018
• Aemcolo FDA Approval History

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).

• FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD) - November 9, 2018
• Yupelri FDA Approval History

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.

• FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma - November 7, 2018
• Primatene Mist FDA Approval History

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.

• Bausch Health Announces U.S. Launch of Bryhali (halobetasol propionate) Lotion, 0.01%, for Plaque Psoriasis In Adults - November 7, 2018
• Bryhali FDA Approval History

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).

• FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer - November 2, 2018
• Lorbrena FDA Approval History

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.

• FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta - November 2, 2018
• Udenyca FDA Approval History

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.

• FDA Approves Dsuvia (sufentanil) Sublingual Tablets for Severe Pain - November 2, 2018
• Dsuvia FDA Approval History

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.

• FDA Approves Sympazan (clobazam) Oral Film for Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome - November 1, 2018
• Sympazan FDA Approval History

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.

• FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira - October 31, 2018
• Hyrimoz FDA Approval History

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.

• FDA Approves Bijuva (estradiol and progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause - October 29, 2018
• Bijuva FDA Approval History

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.

• FDA Approves Xofluza (baloxavir marboxil) for the Treatment of Acute Uncomplicated Influenza - October 24, 2018
• Xofluza FDA Approval History

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.

• Spectrum Pharmaceuticals Receives FDA Approval of Khapzory (levoleucovorin) for Injection - October 23, 2018
• Khapzory FDA Approval History

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.

• FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer - October 16, 2018
• Talzenna FDA Approval History

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.

• FDA Approves Yutiq (fluocinolone acetonide intravitreal implant) for Chronic Non-Infectious Posterior Segment Uveitis - October 15, 2018
• Yutiq FDA Approval History

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.

• FDA Approves Tegsedi (inotersen) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis - October 5, 2018
• Tegsedi FDA Approval History

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).

• FDA Approves Revcovi (elapegademase-lvlr) for Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID) - October 5, 2018
• Revcovi FDA Approval History

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).

• FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections - October 2, 2018
• Nuzyra FDA Approval History

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.

• FDA Approves Seysara (sarecycline) for the Treatment of Moderate to Severe Acne - October 2, 2018
• Seysara FDA Approval History

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.

• FDA Approves Xyosted (testosterone enanthate) Injection for Testosterone Replacement Therapy in Adult Males - October 1, 2018
• Xyosted FDA Approval History

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).

• FDA Approves Libtayo (cemiplimab-rwlc) for Advanced Cutaneous Squamous Cell Carcinoma - September 28, 2018
• Libtayo FDA Approval History