News | July 15, 2021
Caplin gets USFDA approval for Sumatriptan
Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache
Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
The drug is used with other HIV medications to help control HIV infection and it helps to decrease the amount of HIV in one’s body so that the immune system can work better
TLD is recommended by WHO, USAID, and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg
Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells
Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
Emtricitabine and Tenofovir Disoproxil Fumarate tablets had estimated annual sales of US $2.1 billion in the U.S. according to IQVIA MAT March 2021
Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).
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