Drug Approval | 17 January 2022
Strides receives USFDA approval for influenza medicine
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval
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
Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022
It will be marketed under the brand name Molunamax
The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health
The Subject Expert Committee (SEC), on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday recommended granting permission to manufacture and market anti-Covid pill molnupiravir for restricted emergency use
The product is expected to be available in a week’s time
It plans to deliver over 300 million doses to the Indian government
Natco Pharma has received approval for Covid 19 drug molnupiravir capsules 200 mg. for Indian market, which will be sold under brand name Molnunat
DCGI approved the drug based on the review of clinical data
Molnupiravir is an orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2
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