USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria
ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains
ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains
Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)
The tablets are indicated for the treatment of pulmonary arterial hypertension
Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19
Zydus was the first to file an ANDA for Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength
The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease
Idiopathic hypersomnia is a life-long condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder
It’s an AB-rated generic therapeutic version of Durezol
It had an estimated market size of US $ 32 million as of June 2021
The group now has 320 approvals and has so far filed over 400 ANDAs
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