Drug Approval | 05 October 2022
Lupin receives approval from USFDA for Darunavir Tablets
The product will be manufactured at Lupin's facility in Nagpur, India.
The product will be manufactured at Lupin's facility in Nagpur, India.
The inspection concluded with no observation (FDA-483) issued.
Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency
The inspection of the facility was conducted from August 16-19, 2022.
Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).
The company will address the observations within a stipulated timeline working with the regulators
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US
This will be an added advantage for Supriya Lifescience Limited in the European market.
The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses
RYALTRIS is a fixed-dose combination therapy that provides relief for the symptoms of SAR, both nasal and ocular, in one easy-to-use nasal spray
Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of US $484 million in the US
One in two women with advanced ovarian cancer has an HRD-positive tumor
NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.
The ANDA was filed as 'First to File' submission on NCE-1 date.
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
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