Drug Approval | July 26, 2022
Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets
The product will be manufactured at Lupin's facility in Nagpur, India.
The product will be manufactured at Lupin's facility in Nagpur, India.
Bisoprolol Fumarate Tablets are used to treat high blood pressure.
Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).
Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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.
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.
Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.
The drug will be manufactured at the group’s topical facility at Ahmedabad
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