Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date
The drug is to be supplied in 105 low and middle-income countries and 10 Indian firms are on the list
It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan
Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain
Nuvaxovid is the first protein-based Covid-19 vaccine to receive approval for provisional registration in Australia
Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain
First launches expected in H1 2022
Oral semaglutide is a co-formulation of GLP-1RA semaglutide with an absorption enhancer SNAC which protects semaglutide from undergoing degradation in the stomach
The company has 47 ANDA's pending approval with the U.S.FDA
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval
Their strong recommendation is based on moderate certainty evidence that it improves survival and reduces the need for ventilation
It is the first monoclonal antibody drug for use in any animal species
The recommended daily dose for Ryaltris is 2 sprays in each nostril twice daily
Nuvaxovid is the first protein-based Covid-19 vaccine granted approval in South Korea
The product will be marketed under store brand labels and is comparable to the brand Zyrtec
Dronedarone tablets USP, 400 mg have an estimated market size of US $ 500 million for twelve months ending September 2021 according to IQVIA
Entacapone tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021, according to IQVIA
Doxycycline Hyclate Delayed Release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
A toll-free helpline to be set up to help doctors and patients
The current annual U.S. market for amphetamine mixed salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg immediate release tablets strengths is approximately US $ 335 million, according to MAT, Oct 2021 IQVIA/IMS Health
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