Drug Approval | August 16, 2021
Zydus Cadila receives final approval for Mesalamine extended-release capsules
The group has a total of 320 ANDA approvals
The group has a total of 320 ANDA approvals
According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules, 100 mg and 150 mg market achieved annual sales of approximately US $1.6 billion
Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis
NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.
It is used to treat low blood pressure that causes severe dizziness or a lightheaded feeling.
Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, are indicated for the treatment of orthostatic dizziness
Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).
The latest addition, a new API facility in Morrisville, North Carolina, will produce key components for solid dosage tablets, capsules, and RNA therapeutics
ANDA approval for 100 mg and 150 mg capsules targeting idiopathic pulmonary fibrosis opens access to a $3.76 billion market in USA
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