USFDA keeps validating and Approving Drugs based on various clinical trials, Safety and other useful data-keeping Patients and Healthcare professionals in Mind, After intensive working on various data submitted bu Pharma/Research company the Panel of USFDA rejects or Approves or sends back for further clarifications or Improvements. The approval by FDA is approval for the Pharma Companies to Market the Researched Molecule/Indications

Following is the List of Drugs/New Indications approved by FDA in May 2020

1. Brand: Fensolvi

Composition: Leuprolide Acetate, Injection

Company: Tolmar Pharmaceuticals Inc

Indication: Precocious Puberty

Date of Approval: 1st May 2020

Highlights

  • GnRH, Indicated in Patients above 2 Yrs age for central precocious puberty

Click to Read Complete Details


2. Drazalex Faspro Injection

Composition: Daratumumab & Hyaluronidase fihj Injection

Company: Janssen Pharmaceuticals, Inc

Indication: Multiple Myeloma

Date of Approval: 1st May 2020

Highlight:

  • Can be administered in 3-5 Minutes (Significantly lesser time)
  • Two-third reduction in Systemic ARR
  • Availability for Patients by 11th May 2020
  • Approved in Combination with Bortezomib, Melphalan, and Prednisone

Click for reading Complete Details


3. Elyxyb – Celecoxib Oral Solution

Composition: Celecoxib Oral Solution for Acute Migraine

Company: Dr. Reddy’s Laboratories

Indication: Migraine

Date of Approval: 5th May 2020

Highlights:

  • Indicated in Acute Migraine with or without aura in Adults
  • Self Micro emulsifying drug Delivery system to improve solubility and Bioavailability
Click to read Complete Details


4. Tabrecta – Capmatinib Tablets

Company: Novartis Pharmaceutical Corporation

Composition: Capmatinib

Indication: Non-Small cell Lung Cancer

Date of Approval: 6th May 2020

Highlights:

  • Oral MET Inhibitor for Metastatic NSCLC
  • Approved for First-line and previously treated Patient regardless of treatment type

Click for Complete Details

 


5. Retevmo – Selpercatinib Capsules

Company: Eli Lilly and Company

Composition: Selpercatinib 40/80 mg Capsules

Indication: Non-Small cell Lung Cancer, Thyroid Cancer

Date of Approval: 08 May 2020

Highlights:

  • Indicated in metastatic rearranged during transfection (RET) fusion-positive NSCLC
  • Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC)
  • It is a selective RET kinase inhibitor
Click Here for Complete Details

6. Qinlock – Ripretinib Tablets 

Company: Deciphera Pharmaceuticals Inc

Composition: Ripretinib 50 mg Tablets

Indication: Gastrointestinal Stromal Tumour

Date of Approval: 15th May 2020

Highlights:

  • Approved for Patients with Advanced Gastro Tumour, and Received previously 3 or more Kinase inhibitors including Imitinib
Click Here for Complete Details

7. Cerianna – Fluoroestradiol F18 Injections

Company: Zionexa USA

Composition: Fluoroestradiol Injections

Indication: Diagnostics

Date of Approval: 20th May 2020

Highlights:

  • Radioactive Diagnostic Agent for use with PET Imaging Agent for Use in Patients with Recurrent or Metastatic Breast Cancer

Read Complete Details:  Cerianna Press Release


8. Kynmobi – Apomorphine HCl Sublingual Film

Company: Sunovion Pharmaceuticals Inc

Composition: Apomorphine HCl 10mg/15mg/20/mg/25mg/30mg Sublingual Film

Indication: Parkinson’s Disease

Date of Approval: 21 May 2020

Highlights:

  • Approved for on-demand management of OFF episodes associated with Parkinson’s disease (PD).
Click for Complete Details

9. Phexxi – Lactic Acid, Citric Acid & Pot. Bitartrate Vaginal Gel

Company: Evofem Biosciences Inc

Composition: Lactic Acid – 1.8%, Citric Acid 1%, Potassium Bitartrate 0.4%

Indication: Contraception

Date of Approval: 22nd May 2020

Highlights:

  • On-Demand Non-Harmonal Vaginal Contraceptive to Maintain pH in range of 3.5-4.5 inhospitable to sperm
Click for Complete Details

10. Artesunate for Injection 

Company: Amivas (US), LLC

Composition: Artesunate 110 mg Powder for Injection & Solvent

Indication: Malaria

Date of Approval: 26th May 2020

Highlights:

  • Initial treatment of Severe Malaria in Children’s and Adults
Click for Complete Details

11. Zilxi Topical Foam – Minocycline

Company: Foamix Pharmaceuticals Ltd

Composition: Minocycline 1.5% Topical Foam

Indication: Acne Rosacea

Date of Approval: 28th May 2020

Highlights:

  • Topical Tetracycline formulation for Inflammatory Lesions of Rosacea in Adults
Click for Complete Details

12. Tauvid Injections – Flortaucipir F 18 Injection

Company: Eli Lilly & Company

Composition: Flortaucipir Injection

Indication: Diagnostic Agent

Date of Approval: 28th May 2020

Highlights:

  • Radioactive Diagnostic Agent for PET Imaging of Brain
Click for Complete Details

13. Oriahnn Capsules – elagolix/estradiol/norethindrone acetate and elagolix

Company: AbbVie Inc

Composition: elagolix/estradiol/norethindrone acetate and elagolix

Indication: Uterine Leiomyomata

Date of Approval: 29th May 2020

Highlights:

  • GnRH receptor Antagonist
  • Indicated for Heavy Menstrual Bleeding associated with Fibroids in Pre Menopausal women
  • First Oral Medication for Treatment of Heavy Menstrual Bleeding

Oriahnn Click for Complete Details


 

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