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15 Jan 2019
Alopecia areata (AA) is associated with a variety of comorbid conditions such as metabolic syndrome, iron deficiency anaemia and Helicobacter pylori infections, a recent meta-analysis has shown.

Original New Drug Application Approvals by US FDA (16 - 30 April 2017)

30 Apr 2017
New drug applications approved by US FDA as of 16 - 30 April 2017 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.

CLINDAMYCIN IN 0.9%SODIUM CHLORIDE
  • Active Ingredient(s): CLINDAMYCIN; SODIUM CHLORIDE
  • Strength: 300MG/5ML; 600MG/50ML; 900MG/50ML
  • Dosage Form: Injectable; Intravenous
  • Company: Celerity Pharms LLC
  • Approval Date: April 20, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of the following:
    • Serious infections caused by susceptible anaerobic bacteria
    • Infections Due to Susceptible Strains of Streptococci, Pneumococci and Staphylococci
    • Lower Respiratory Tract Infections
    • Skin and Skin Structure Infections
    • Gynecological Infections
    • Intra-abdominal Infections
    • Septicemia
    • Bone and Joint Infections
  • Approved Label: 04/20/2017 (PDF)

ROXYBOND
  • Active Ingredient(s): OXYCODONE HYDROCHLORIDE
  • Strength: 5MG; 15MG; 30MG
  • Dosage Form: Oral tablet
  • Company: Inspirion Delivery Sciences LLC
  • Approval Date: April 20, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
  • Approved Label: 04/20/2017 (PDF)

RENFLEXIS
  • Active Ingredient(s): INFLIXIMAB-ABDA
  • Strength: 100MG
  • Dosage Form: Injectable; Injection
  • Company: Samsung Bioepsis Co Ltd
  • Approval Date: April 21, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for
    • Crohn’s Disease
      • reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
      • reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease
    • Pediatric Crohn’s Disease
      • reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy
    • Ulcerative Colitis
      • reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
    • Rheumatoid Arthritis in combination with methotrexate:
      • reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease
    • Ankylosing Spondylitis
      • reducing signs and symptoms in patients with active disease
    • Psoriatic Arthritis
      • reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function
    • Plaque Psoriasis
      • treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate
  • Approved Label: 04/21/2017 (PDF)

XATMEP
  • Active Ingredient(s): METHOTREXATE
  • Strength: 2.5MG/ML
  • Dosage Form: Oral Solution
  • Company: Silvergate Pharms
  • Approval Date: April 25, 2017
  • Chemical Type: Type 3 - New Dosage Form
  • Indication(s): Indicated for the:
    • Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen
    • Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy
  • Approved Label: 04/25/2017 (PDF)

BRINEURA
  • Active Ingredient(s): CERLIPONASE ALFA
  • Strength: 30MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Biomarin Pharm
  • Approval Date: April 27, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
  • Approved Label: 04/27/2017 (PDF)

RYDAPT
  • Active Ingredient(s): MIDOSTAURIN
  • Strength: 25MG
  • Dosage Form: Oral capsule
  • Company: Novartis Pharms Corp
  • Approval Date: April 28, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with:
    • Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-headache, and dyspnea. positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.
    • Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL)
  • Approved Label: 04/28/2017 (PDF)

TYMLOS
  • Active Ingredient(s): ABALOPARATIDE
  • Strength: 2000MCG/ML
  • Dosage Form: Injectable; Subcutaneous
  • Company: Radius Health Inc
  • Approval Date: April 28, 2017
  • Chemical Type: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture
  • Approved Label: 04/28/2017 (PDF)

ALUNBRIG
  • Active Ingredient(s): BRIGATINIB
  • Strength: 30MG; 90MG
  • Dosage Form: Oral tablet
  • Company: Ariad
  • Approval Date: April 28, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Approved Label: 04/28/2017 (PDF)
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Most Read Articles
15 Jan 2019
Alopecia areata (AA) is associated with a variety of comorbid conditions such as metabolic syndrome, iron deficiency anaemia and Helicobacter pylori infections, a recent meta-analysis has shown.