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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
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
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
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
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).
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
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
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
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
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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