Policy | May 24, 2021
NATCO Pharma receives USFDA approval for Lenalidomide capsules
NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
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).
Karkinos’ model aims to close both gaps by combining World Health Organization-recommended HPV DNA testing with a digitally enabled continuum of care
The collaboration comes at a time when access to high-quality fertility treatment remains uneven, despite rapid market expansion
Approval makes it the first and only therapy in the EU indicated for both acute and chronic hepatitis C, supported by Phase 3 data
The filing is backed by positive Phase 3 results recently published in JAMA Neurology
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines
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