Drug Approval | 01 July 2022
Lupin receives approval from USFDA for Paliperidone extended-release tablets
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S
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
The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects
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.
It´s the first trial to demonstrate the benefits of dual pathway inhibition
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation
Alopecia areata usually presents as a few small bald patches in the head
Acceptance based on results from the phase 3 KEYNOTE-091 trial
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.
Tislelizumab is now approved in nine indications in China
Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood
TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis.
he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.
Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.
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