January 2020 FDA Approvals

Pharmacy Times, February 2020, Volume 87, Issue 2

Check out all of the NDA and BLA approvals from the FDA in January.

Drug Name

Indication

Manufacturer

Submission Classification

Date Approved

Porfimer Sodium (Photofrin)

Reduction of obstruction in patients with endobronchial NSCLC

Pinnacle Biologics

Labeling

1/1/2020

Tipiracil Hydrochloride; Trifluridine (Lonsurf)

Colon, rectal, or stomach cancer

Taiho Oncology

Labeling

1/1/2020

Sirolimus (Rapamune)

Prophylaxis of organ rejection for renal transplants

PF Prism CV

Labeling

1/2/2020

Toremifene Citrate (Fareston)

Treatment of metastatic breast cancer

Kyowa Kirin

Labeling

1/3/2020

Vincristine Sulfate (Marqubo Kit)

Treatment for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia

Acrotech

Labeling

1/3/2020

Azelaic Acid (Azelex)

Topical treatment for inflammatory acne vulgaris

Almirall

Labeling

1/6/2020

Pegfilgrastim (Neulasta)

Anti-infective for patients receiving myelosuppressive anti-cancer drugs

Amgen

Biologic Approval

1/6/2020

Doctaxel

Treatment for locally advanced or metastatic breast cancer

Sandoz

Labeling

1/6/2020

Bedaquiline Fumarate (Sirturo)

Diarylquinoline antimycrobacterial drug

Janssen Therapeutics

Labeling

1/6/2020

Balsalazide Disodium (Giazo)

Treatment for active ulcerative colitis in males 18 and older

Valeant Pharms Intl.

Labeling

1/7/2020

Levoleucovorin Calcium (Fusilev)

To reduce toxicity of high-dose methotrexate therapy

Acrotech

Labeling

1/8/2020

Somatropin (Genotropin)

Treatment for children with growth failure

Pharmacia

Labeling

1/8/2020

Pembrolizumab (Keytruda)

Treatment for recurrent or metastatic cervical cancer

Merck Sharp Dohme

Biologic Approval

1/8/2020

Belinostat (Beleodaq)

Treatment for relapsed or refractory peripheral T-cell lymphoma

Acrotech

Labeling

1/8/2020

Gemcitabine Hydrochloride (Infugem)

For treatment of advanced ovarian cancer

Sun Pharma

Labeling

1/8/2020

Avapritinib (Ayvakit)

Treatment for adults with unresectable or metastatic GIST

Blueprint Medicines Corp.

New Molecular Entity

1/9/2020

Ipratropium Bromide (Atrovent HFA)

Bronchodilator for maintenance treatment of bronchospasm associated with COPD

Boehringer Ingelheim

Labeling

1/10/2020

Flutemetamol F-18 (Vizamyl)

PET imaging of the brain

GE Healthcare

Labeling

1/10/2020

Ponatinib Hydrochloride (Iclusig)

Treatment for adults with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia

Ariad

Labeling

1/10/2020

Florebetaben F-18 (Neuraceq)

PET imaging of the brain

Life Molecular

Labeling

1/10/2020

Cocaine Hydrochloride (Numbrino)

Induction of local anesthesia of the mucous membraines

Cody Laboratories Inc.

Drug already marketed without approved NDA

1/10/2020

Diazepam (Valtoco)

Acute treatment of intermittent, stereotypic episodes of frequent seizure activity

Neurelis Inc

New dosage form

1/10/2020

Ocrelizumab (Ocrevus)

Treatment for relapsing forms of multiple sclerosis

Genentech Inc

Biologic Approval

1/10/2020

Mechlorethamine Hydrochloride (Valchlor)

Topical treatment for Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma

Helsinn

Labeling

1/13/2020

Diclofenac Epolamine (Licart)

Topical treatment for acute pain due to minor strains or sprains

Ibsa Inst Bio

Labeling

1/13/2020

Cytarabine; Daunorubicin (Vyxeos)

Treatment of adults with acute myeloid leukemia

Celator Pharms

Labeling

1/13/2020

Ruxolitinib Phosphate (Jakafi)

Treatment for intermediate or high-risk myelofibrosis

Incyte Corp

Labeling

1/14/2020

Pasireotide Diaspartate (Signifor)

Treatment for adults with Cushing's disease

Novartis

Efficacy

1/15/2020

Tigecycline (Tygacil)

Treatment for adults with community-acquired bacterial pneumonia

PF Prism CV

Labeling

1/16/2020

Cyanocobalamin (CaloMist)

Treats vitamin B12 deficiency in people with pernicious anemia

Par Pharm

Labeling

1/16/2020

Pertuzumab (Perjeta)

Neoadjuvant treatment for HER2+, locally advanced, inflammatory, or early stage breast cancer

Genentech

Biologic Approval

1/16/2020

Ferric Derisomaltose (Monoferric)

Intravenous treatment for adults with iron deficiency anemia

Pharmacosmos AS

New formulation or new manufacturer

1/16/2020

Semaglutide (Ozempic)

Improves glycemic control in adults with type 2 diabetes

Novo

Efficacy

1/16/2020

Semaglutide (Rubelsus)

Improves glycemic control in adults with type 2 diabetes

Novo

Labeling

1/16/2020

Infliximab-qbtx (Ixifi)

Reducing signs and symptoms in patients with active ankylosing spondylitis

Pfizer Inc

Biologic Approval

1/16/2020

Omeprazole and Clarithromycin and Amoxicillin

Prevents stomach ulcers caused by infection with Helicobacter pylori

Cumberland Pharms

Labeling

1/17/2020

Belimumab (Benlysta)

Treatment for adults with active, autoantibody+, systemic lupus erythematosus

Human Genome Sciences Inc.

Biologic Approval

1/17/2020

Belimumab (Benlysta)

Treatment for adults with active, autoantibody+, systemic lupus erythematosus

Glaxosmithkline LLC

Biologic Approval

1/17/2020

Liothyronine Sodium (Cytomel)

Replacement therapy for congenital or acquired hypothyroidism

King Pharms

Labeling

1/21/2020

Econazole Nitrate (Spectazole)

Topical treatment for tinea pedis, tinea cruris, and tinea corporis

Alvogen

Labeling

1/21/2020

Ribociclib Succinate (Kisqali)

Treatment of pre/perimenopausal women with HR+, HER2- advanced or metastatic breast cancer

Novartis

Labeling

1/21/2020

Letrozole, Ribociclib Succinate (Kisqali Femara Co-Pack)

Treatment of pre/perimenopausal women with HR+, HER2- advanced or metastatic breast cancer

Novartis

Labeling

1/21/2020

Teprotumumab-TRBW (Tepezza)

Treatment for adults with thyroid eye disease

Horizon Therapeutics Ireland

Biologics Approval

1/21/2020

Everolimus (Afinitor)

Treatment for adults with advanced RCC

Novartis

Labeling

1/22/2020

Ioversol (Optiray 160, 240, 300, 320, 350)

For children for angiocardiography

Liebel-Flasheim

Labeling

1/23/2020

Ziprasidone Hydrochloride (Geodon)

Monotherapy for adults with manic or mixed episodes of bipolar I disorder

Pfizer

Labeling

1/23/2020

Rituximab (Rituxan)

Treatment for certain types of cancer

Genentech

Biologic Approval

1/23/2020

Axitinib (Inlyta)

Treatment for advanced renal cell carcinoma

PF Prism CV

Labeling

1/23/2020

Tazemetostat (Tazverik)

Treatment for patients 16 and older with metastatic or locally advanced epithelioid sarcoma

Epizyme Inc

New molecular entity

1/23/2020

Cont.

Drug Name

Indication

Manufacturer

Submission Classification

Date Approved

Vinorelbine Tartrate (Navelbine)

Combination treatment for patients with locally advanced ormetastatic non-small cell lung cancer

Pierre Fabre

Labeling

1/24/2020

Vigabatrin (Sabril)

Adjunctive therapy for patients with refractory complex partial seizures

Lundbeck Pharms LLC

Efficacy

1/24/2020

Isotretinoin (Absorica)

Retinoid indicated for treatment of severe recalcitrant nodular acne

Sun Pharms Industries Inc

REMS

1/24/2020

Fisaxomicin (Dificid)

For adults with CLostridium difficile-associated diarrhea

Cubist Pharms LLC

Efficacy

1/24/2020

Dapagliflozin (Farxiga)

Improves glycemic control for adults with type 2 diabetes

Astrazeneca AB

Labeling

1/24/2020

Canagliflozin (Invokana)

Improves glycemic control for adults with type 2 diabetes

Janssen Pharms

Labeling

1/24/2020

Canagliflozin; Metformin Hydrochloride (Invokamet)

Combination therapy to improve glycemic control for adults with type 2 diabetes

Janssen Pharms

Labeling

1/24/2020

Empagliflozin (Jardiance)

Improves glycemic control for adults with type 2 diabetes

Boehringer Ingelheim

Labeling

1/24/2020

Dapagliflozin; Metformin Hydrochloride (Xigduo XR)

Improves glycemic control for adults with type 2 diabetes

Astrazeneca AB

Labeling

1/24/2020

Empagliflozin; Linagliptin (Glyxambi)

Improves glycemic control for adults with type 2 diabetes

Boehringer Ingelheim

Labeling

1/24/2020

Empagliflozin; Metformin Hydrochloride (Synjardy and Synjardy XR)

Improves glycemic control for adults with type 2 diabetes

Boehringer Ingelheim

Labeling

1/24/2020

Dapagliflozin; Saxagliptin Hydrochloride (Qtern)

Improves glycemic control for adults with type 2 diabetes

Astrazeneca AB

Labeling

1/24/2020

Ertugliflozin (Steglatro)

Improves glycemic control for adults with type 2 diabetes

Merck Sharp Dohme

Labeling

1/24/2020

Ertugliflozin; Sitagliptin Phosphate (Steglujan)

Improves glycemic control for adults with type 2 diabetes

Merck Sharp Dohme

Labeling

1/24/2020

Ertugliflozin; Metformin Hydrochloride (Segluromet)

Improves glycemic control for adults with type 2 diabetes

Merck Sharp Dohme

Labeling

1/24/2020

Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride (Qternmet XR)

Improves glycemic control for adults with type 2 diabetes

Astrazeneca AB

Labeling

1/24/2020

Trastuzumab-QYYP (Trazimera)

For treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma

Pfizer Inc

Biologic Approval

1/24/2020

Sodium Chloride 0.9%

Used to treat or prevent sodium loss

Baxter Healthcare

Manufacturing

1/27/2020

Empagliflozin; Linagliptin; Metforming Hydrochloride (Trijardyn XR)

Improves glycemic control for adults with type 2 diabetes

Boehringer Ingelheim

New combination

1/27/2020

Fremanezumab-VFRM (Ajovy)

Preventive treatment of migraine in adults

Teva Pharms USA

Biologic Approval

1/27/2020

Miconazole Nitrate (Monistat)

For treatment of vaginal yeast infections

Medtech Products

Labeling

1/28/2020

Fosphenytoin Sodium (Cerebyx)

Treatment for generalized tonic-clonic status epilepticus and prevention and treatment of seizures occuring during neurosurgery

Parke Davis

Labeling

1/28/2020

Ribavirin (Rebetol)

For treatment of chronic hepatitis C

Merck Sharp Dohme

Labeling

1/28/2020

Vasopressin

Indicated for prevention and treatment of postoperative abdominal distention

American Regent, Inc

Drug already marketed without approved NDA

1/28/2020

Cont.

Drug

Indication

Manufacturer

Submission Classification

Date Approved

Octreotide Acetate (Bynfezia Pen)

Treatment of adult patients with severe diarrhea and flushing episodes associated with metastatic carcinoid tumors

Sun Pharm Inds LTD

New formulation or new manufacturer

1/28/2020

Fluocinolone Acetonide (Derma-Smoothe/FS)

Topical treatment of moderate to severe atopic dermatitis

Hill Dermac

Labeling

1/29/2020

Secukinumab (Cosentyx)

Treatment for moderate to severe plaque psoriasis

Novartis Pharms Corp

Biologic Approval

1/29/2020

Suvorexant (Belsomra)

Treatment for insomnia

Merck Sharp Dohme

Efficacy

1/29/2020

Irinotecan Hydrochloride (Camptosar)

Treatment for patients with metastatic carcinoma of the colon or rectum

Pfizer Inc

Labeling

1/30/2020

Pramipexole Dihydrochloride (Mirapex)

For treatment of moderate-to-severe primary Restless Leg Syndrome

Boehringer Ingelheim

Labeling

1/30/2020

Omeprazole Magnesium (Prilosec OTC)

Short-term treatment of active duodenal ulcer or active benign gastric ulcer

Astrazeneca Pharms

Labeling

1/30/2020

Dutasteride (Avodart)

For treatment of symptomatic benign prostatic hyperplasia

Glaxosmithkline

Labeling

1/30/2020

Epinephrine (Epi EZ Pen Jr.)

Emergency treatment of allergic reactions

Mylan Specialty LP

Labeling

1/31/2020

Epinephrine (Epi Pen)

Emergency treatment of allergic reactions

Mylan Specialty LP

Labeling

1/31/2020

Epinephrine (Epi Pen EZ Pen)

Emergency treatment of allergic reactions

Mylan Specialty LP

Labeling

1/31/2020

Epinephrine (Epi Pen Jr.)

Emergency treatment of allergic reactions

Mylan Specialty LP

Labeling

1/31/2020

Minoxidil (Rogain, Men and Women's)

Treatment of hypertension symptomatic or associated with target organ damage

Johnson and Johnson

Labeling

1/31/2020

Vilazodone Hydrochloride (Viibryd)

Treatment for major depressive disorder

Allergan

Labeling

1/31/2020