Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US
The company has received five final approvals
Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis
The product is expected to be launched in December 2023
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
US FDA approval based on NEURO-TTRansform Phase III results
The plant is yet to start commercial operations
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Studies have demonstrated that ZYIL1 is highly potent and can suppress inflammation caused by NLRP3 inflammasome activation
Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus
Lacosamide is indicated to treat partial-onset seizures
Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cell
The product will be manufactured at Lupin's Pithampur facility in India
Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
The CVMP recommends the product for approval for the treatment and persistent killing of fleas
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