Drug Approval | 18 October 2022
Zydus receives tentative approval from USFDA for Roflumilast tablets
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data
Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures
The company increases its efficiency and is able to face the growing demand for its services.
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
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
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