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India Business News: Aurobindo Pharma has received approval from the US Food & Drug Administration (USFDA) for its long-acting Granulocyte colony-stimulating factor (G-CSF
The product is bioequivalent and therapeutically equivalent to the reference listed drug Vascepa of Amarin. It will be manufactured at the company's facility in Bengaluru, it added. The Icosapent Ethyl capsules have a market size of around USD 1.3 billion, Strides said, citing IQVIA.
Zydus Lifesciences has gained the US Food and Drug Administration's (FDA) approval to produce and market its Indomethacin suppositories. The drug is used to treat moderate to severe rheumatoid arthritis and acute flares of chronic disease, among other conditions. Zydus has been awarded 180-day CGT exclusivity to market the product after US authorities deemed there was a lack of competition.
Pimavanserin is an atypical antipsychotic and is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
Alembic gets USFDA nod for generic hypertension treatment drug