News | July 06, 2022
Cipla updates on US FDA product-specific pre-approval inspection
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
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.
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
Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally
ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.
Alopecia areata usually presents as a few small bald patches in the head
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
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