The vaccine further advances Pfizer’s vaccine portfolio and builds on more than 20 years of expertise and knowledge in the prevention of meningococcal disease
Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials
This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years
Glenmark's current portfolio consists of 188 products authorized for distribution in the US
The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally
Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch
The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials
The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg
This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals
The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products
The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets
The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The delegation's visit covered a wide range of topics
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