Strides receives FDA nod for 2 generics
Strides’ subsidiary, Strides Pharma Global, Singapore, has received the Food and Drug Administration's approval for two generics.
Strides has received the FDA OK for Icosapent Ethyl Capsules 0.5 gram and 1 gram, which is the generic of Amarin’s Vascepa.
Strides’s Icosapent Ethyl Capsules is approved for the following indication: as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
The product complements Strides’ range of approved soft gelatin capsules.
Icosapent Ethyl Capsules has a market size of $ 1.3 billion, per IQVIA, and will be manufactured at the company’s facility in Bengaluru.
Stride’s subsidiary, Strides Pharma Global, Singapore, also has received FDA approval for Efavirenz (600 mg), Emtricitabine (200 mg), Tenofovir Disproxil Fumurate (300 mg) tablets, which is the generic of Gilead Sciences’ Atripla Tablets.
[Read more: Strides Pharma receives FDA nod for generic Renvela]
The EET tablet has a market value of $7.5 million, per IQVIA. The product will be manufactured at the company’s facility in Bengaluru.
Strides’ EET tablets belong to a class of medication known as antiretrovirals. This fixed-dose, triple-drug combination medication is indicated for treatment of HIV-1 infection in adult patients weighing at least 40 kgs.
[Read more: Strides Pharma obtains FDA clearance for generic Actigal]