Drug Approval | September 12, 2021
US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
Revlimid is a blood cancer drug with sales of US $ 12.1 billion in 2020
Labetalol hydrochloride injection USP is indicated for the control of blood pressure in severe hypertension.
Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate)
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo
The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India
First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
In 2018 NATCO and Alvogen had filed an Abbreviated New Drug Application (ANDA) with PIV certification for the generic version of the product
Price erosion, weak demand for acute portfolio and low ANDA approvals in the US weighed on the performance of Indian pharma in Q1FY22. However, the scenario is expected to change in H2FY22 when new approvals and inspections resume
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