Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
Extends patent protection for Microbion's proprietary inhaled pravibismane for the treatment of pulmonary infections to 2039
SCYNEXIS will receive an upfront payment of $90 million with future performance-based milestone payments and tiered royalties
Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults
The facility is over 79,000 square feet and is equipped with packaging lines
The observations are procedural in nature
The company will be submitting the responses to US FDA observations within stipulated timeline
Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.
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