Drug Approval | November 22, 2023
Lupin receives approval from USFDA for Pitavastatin Tablets
Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol
Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.
XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
This product will be manufactured at Lupin’s Pithampur facility in India
This product will be manufactured at Lupin's Nagpur facility in India
NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023
The inspection of the facility conducted from August 7 to August 11, 2023
The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
The company is confident of addressing all the observations within the stipulated time
CB03 is a candidate drug for the treatment of ALS and other central nerve system (CNS) diseases
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