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

Can Just Three Days of Junk Food Harm Your Brain? Science Says YesMarch 08, 2025
Your Night Shifts Might Be Damaging Your DNA: Here’s How to Fight BackMarch 08, 2025
India’s Women: Empowered on Paper, Struggling in RealityMarch 08, 2025
NephroPlus to Launch Nationwide Free Health Screening Campaign to Commemorate World Kidney Day 2025 March 07, 2025
Skinny But Sick? Is our Body Mass Index Misleading UsMarch 07, 2025
Scientists Stumble Upon a Cancer-Fighting Secret Hidden in Your Medicine CabinetMarch 07, 2025
The Bitter Truth About Butter: Is our Favourite Spread Cutting our Life Short?March 07, 2025
March 07, 2025
March 06, 2025
University of Leeds scientists offer hope for people facing chronic painMarch 06, 2025
Impact of excessive use of gym supplements on gym enthusiastsMarch 06, 2025
Himalaya Wellness Launches the Himalaya 1derwoman Project, Inspiring Young Girls to Be #1March 06, 2025
Gujarat’s Medical Education Expansion: A Game Changer or Just Numbers on Paper?March 06, 2025
440 Million at Risk: Is India Becoming the Next Obesity Capital?March 06, 2025
Mystery Illness Claims Lives in Chhattisgarh: Is It a Health Crisis in the Making?March 06, 2025
Rising obesity rate in kidsMarch 05, 2025
India’s Clinical Trials Market: Can We Leap from Underdog to Global Leader?March 05, 2025
India’s GBS Outbreak: Is Contaminated Water Fueling a Paralysis Crisis? March 05, 2025
3-Day-Old Baby Born with One Lung Gets a New Lease on Life at SRM Global Hospitals after Rare SurgeryMarch 04, 2025
3-Day-Old Baby Born with One Lung Gets a New Lease on Life at SRM Global Hospitals after Rare SurgeryMarch 04, 2025