Strides Pharma receives USFDA approval for Prednisone tablets

▴ Strides Pharma receives USFDA approval for Prednisone tablets
Strides Pharma gets USFDA approval for their anti-inflammatory drug Prednisone (tablets)

Drug firm Strides Pharma Science reported,  approval from the US health regulator for generic Prednisone tablets used as an anti-inflammatory medication. Strides Pharma  has received approval for Prednisone tablets USP in the strength of 1 mg from the United States Food & Drug Administration (USFDA), Strides Pharma Science said in a filing to the BSE.

The product is a generic version of Schering Corporation's Meticorten tablets in the same strength, it added. The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market,the filing said.

According to IQVIA MAT July 2020 data, the US market for Prednisone tablets USP 1 mg is approximately USD 12 million (about Rs 88 crore), it added. Prednisone belongs to a class of drugs known as corticosteroids and is used as an anti-inflammatory or an immunosuppressant medication.

It is used in treatment of different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders, Strides said. The company has 126 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 89 ANDAs have been approved and 37 are pending approval,it added.

Recently, the company also USFDA approval for Ursodiol tablets USP in the strengths of 250 mg and 500 mg from the United States Food and Drug Administration (USFDA) for treatment of PBC.

PBC is a progressive disease of the liver caused by a buildup of bile within the liver that results in damage to the small bile ducts that drain bile from the liver.

"Strides Pharma Global, Singapore, has received approval for ," the company said in a regulatory filing.

The product is a generic version of Urso 250 tablets, 250 mg, and Urso Forte Tablets, 500 mg, of Allergan Sales, LLC.

Quoting IQVIA moving annual total (MAT) June 2020 data, Strides Pharma Science said the US market for Ursodiol tablets USP, 250 mg and 500 mg, is approximately $35 million.

According to the company , the product will be manufactured at the company''s flagship facility at Bengaluru and will be marketed by Strides Pharma in the US markets.

Tags : #StridesPharmaUSFDAApproval #PrednisoneTablets #IQVIAMat #PBCofLiver #LatestPharmaApprovalNewsUpdateSep4 #LatestPharmaNewsUpdateSep4 #StridesPharmaNewsUpdate

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

The Ethics of Live Surgery Broadcasts: NMC Seeks Public OpinionMay 17, 2024
Successful Removal of 3.7 KG Large Abdominal Tumor from 14-Year-Old Somalian Girl at KIMS Cuddles HospitalMay 16, 2024
iLEAD Sets a Precedent by Launching a Graphic Anthology Authored by Multimedia, Animation and Graphics Students May 16, 2024
Ramaiah Memorial Hospital Launches Novel Intra-Operative Radiation Therapy (IORT); Achieves significant advancement in Cancer Treatment to Enhance Quality of LifeMay 16, 2024
IIITH Announces Product Management Summer SchoolMay 16, 2024
Çelebi India's Delhi Cargo Terminal Successfully Handles Airbus H125 Helicopter ShipmentMay 16, 2024
Plant-Based Diets and Prostate Cancer: New UCSF Study Shows Promising ResultsMay 16, 2024
National Medical Commission Approves 112 New Medical CollegesMay 16, 2024
Study Suggests That Chemotherapy Results in Physical Decline for Older Women with Breast CancerMay 16, 2024
Google DeepMind's AlphaFold 3: Revolutionizing Drug Discovery with AIMay 16, 2024
Hester Biosciences Ltd reports Consolidated Revenue growth of 18% at Rs. 79.3 crore, EBITDA up 37% to Rs. 16.4 crore and Net Profit up 12% to Rs. 6.40 crore in Q4FY24May 16, 2024
Akshay Tritiya Parna Mahotsav heldMay 16, 2024
IT Minister Sridhar Babu to grace the 10th National Facilities Managers Summit-2024, to be held in the cityMay 15, 2024
Alarming Study Reveals Cancer-Causing Chemicals in Car InteriorsMay 15, 2024
India's Thalassemia Challenge: The Importance of Early Screening and TreatmentMay 15, 2024
The Dangers of Ultra-Processed Foods: A 30-Year Study Raises AlarmsMay 15, 2024
Unique Genetic Risk Factors for Breast Cancer Found in African Ancestry StudyMay 15, 2024
AsiaMedic partners with Sunway to establish new diagnostic imaging centreMay 14, 2024
Kamineni Doctors Successfully Remove Bone Stuck Near Heart in Elderly PatientMay 14, 2024
On International Nurses Day, American Oncology Institute (AOI) launches #TheExtraordinaryCareGiver Campaign as Tribute to Oncology NursesMay 14, 2024