The FDA's Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people
Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
HealthCare Royalty Partners funding supports the ongoing launch of IBSRELA in the United States
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S
Lacosamide Injection is used to treat partial-onset seizures.
Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia
Analysis of Post-Marketing Safety Data Shows Consistent Findings with Safety Profile Reported in Clinical Trials of Edaravone
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