Drug Approval | 21 September 2022
Tezspire approved in the EU for the treatment of severe asthma
First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations
First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations
Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase III treatment trial
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
The objective of this study is to evaluate the efficacy of ASC22 (Envafolimab) combined with Chidamide on the viral reservoirs of latently infected cells in HIV patients.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder
Rymti is indicated in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, and paediatric plaque psoriasis
Japan’s Ministry of Health, Labour and Welfare (MHLW) has recently approved AstraZeneca's long-acting antibody combination “Evusheld” for the prevention ) and treatment of COVID-19.
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (RLD Suprep Bowel Prep Kit) had estimated annual sales of US $202 mn in the US
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings
iNCOVACC was developed in partnership with Washington University St. Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy
Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares
The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04
The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
The unit has filed 2 Derma products and 1 MDI product.
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