Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.
The GMP facility is equipped with state of art machinery for the needs of Global commercial requirements
Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dr. Reddy's Fesoterodine Fumarate Extended-Release Tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30.
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
The vaccine is under FDA review
Sanofi will begin to ship their vaccines helping to ensure more people will be immunized
The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.
Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk
This multicenter, open-label Phase I study is designed to assess the safety and tolerability
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.
It is a two dose vaccine to be administered intramuscularly at 28 days apart
Safety in these pediatric populations was consistent with the known safety profile across approved adult and pediatric indications1,2
First and only PARP inhibitor to improve invasive disease-free survival in patients
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