Original New Drug Application Approvals by US FDA (01 - 15 November 2019)

New drug applications approved by US FDA as of 01 - 15 November 2019 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

IBRANCE

• Active Ingredient(s): Palbociclib
• Strength: 75 mg; 100 mg; 125 mg
• Dosage Form(s) / Route(s): Tablet; oral
• Company: Pfizer, Inc.
• Approval Date: 01 November 2019
• Submission Classification: Efficacy
• Indication(s): Indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
• an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men or
• fulvestrant in patients with disease progression following endocrine therapy.
• Approved Label: 01 November 2019 (PDF)

TALICIA

• Active Ingredient(s): Omeprazole magnesium; amoxicilin; rifabutin
• Strength: 10 mg; 250 mg; 12.5 mg
• Dosage Form(s) / Route(s): Capsule, delayed release; oral
• Company: Redhill Biopharma, Ltd.
• Approval Date: 01 November 2019
• Submission Classification: Type 4 - New Combination
• Indication(s): Indicated for the treatment of Helicobacter pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of TALICIA and other antibacterial drugs, TALICIA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 
• Approved Label: 01 November 2019 (PDF)

ZIEXTENZO

• Active Ingredient(s): Pegfilgrastim-bmez
• Strength: 6 mg/0.6 mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Sandoz, Inc.
• Approval Date: 04 November 2019
• Submission Classification: Not available
• Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
• Approved Label: 04 November 2019 (PDF)

EPINEPHRINE

• Active Ingredient(s): Epinephrine
• Strength: 1 mg/10 mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Hospira, Inc.
• Approval Date: 05 November 2019
• Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
• Indication(s):Not available
• Approved Label: Not available

ABSORICA LD

• Active Ingredient(s): Isotretinoin
• Strength: 8 mg; 16 mg; 20 mg; 24 mg; 28 mg; 32 mg
• Dosage Form(s) / Route(s): Capsule; oral
• Company: Sun Pharm Inds Ltd.
• Approval Date: 05 November 2019
• Submission Classification: Not available
• Indication(s): Indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
• Approved Label: 05 November 2019 (PDF)

EXEM FOAM

• Active Ingredient(s): Air polymer-type A
• Strength: 5 mL
• Dosage Form(s) / Route(s): Foam; intrauterine
• Company: Giskit B.V.
• Approval Date: 07 November 2019
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.
• Approved Label: 07 November 2019 (PDF)

REBLOZYL

• Active Ingredient(s): Luspatercept-aamt
• Strength: 25 mg/vial; 75 mg/vial
• Dosage Form(s) / Route(s): Powder; subcutaneous
• Company: Celgene Corp
• Approval Date: 08 November 2019
• Submission Classification: Not available
• Indication(s): Indicated for the treatment of anemia in:
• Adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
• Approved Label: 08 November 2019 (PDF)

BRUKINSA

• Active Ingredient(s): Zanubrutinib
• Strength: 160 mg; 320 mg
• Dosage Form(s) / Route(s): Capsule; oral
• Company: Beigene USA, Inc.
• Approval Date: 14 November 2019
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 
• Approved Label: 14 November 2019 (PDF)

FETROJA

• Active Ingredient(s): Cefiderocol
• Strength: 1 g/vial
• Dosage Form(s) / Route(s): Powder; intravenous
• Company: Shionogi, Inc.
• Approval Date: 14 November 2019
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Gram-negative microorganisms
• Approved Label: 14 November 2019 (PDF)

ADAKVEO

• Active Ingredient(s): Crizanlizumab-tmca
• Strength: 100 mg/10 mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Novartis Pharms Corp.
• Approval Date: 15 November 2019
• Submission Classification: Not available
• Indication(s): Indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.
• Approved Label: 15 November 2019 (PDF)

ABRILADA

• Active Ingredient(s): Adalimumab-afzb
• Strength: 40 mg/0.8 mL; 20 mg/0.4 mL; 10 mg/0.2 mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Pfizer, Inc.
• Approval Date: 15 November 2019
• Submission Classification: Not available
• Indication(s): Indicated for treatment of:
• Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
• Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older.
• Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
• Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
• Adult Crohn's Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab products.
• Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.
• Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
• Approved Label: 15 November 2019 (PDF)