Alembic Pharma receives US FDA final approval for Pirfenidone tablets
Pirfenidone Tablets are indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF)
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Browsing Tag
US FDA approval
Sanofi’s Dupixent wins US approval for bigger use
Sanofi's regulatory filing for EoE is under review by the European Medicines Agency (EMA)
Glenmark Pharma receives ANDA approval for Abiraterone Acetate tablets USP, 500 mg
The tablets are a generic version of Zytiga Tablets, 500 mg, of Janssen Biotech
Sun Pharma announces US FDA approval for generic Mesalamine Extended Release capsules
The generic product approval is based on Pentasa Extended Release Capsules, 500 mg as a reference product, the statement added
Alembic Pharma announces US FDA final approval for Arformoterol Tartrate Inhalation Solution
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Brovana Inhalation Solution, 15 mcg/2…
Glenmark Pharma receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate…
The drug is the generic version of Enstilar Foam, 0.005%|0.064%, of Leo Pharma AS
Lupin receives approval from US FDA for Pregabalin capsules
The product will be manufactured at Lupin’s facility in Aurangabad
Aleor Dermaceuticals receives US FDA final approval for Docosanol cream
Docosanol Cream, 10% (OTC) is used for cold sore/fever blisters on the face or lips
Aurobindo Pharma gets US FDA nod for generic cancer drug Bortezomib
The product is the generic version of Reference Listed Drug (RLD) Velcade of Takeda Pharma
Zydus receives final approval from US FDA for Bortezomib for injection
Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma