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Results For "U.S.-FDA"

205 News Found

Lupin receives approval from U.S. FDA for Varenicline Tablets
News | December 07, 2023

Lupin receives approval from U.S. FDA for Varenicline Tablets

Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.


Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
Drug Approval | September 30, 2023

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


Lupin receives approval from U.S. FDA for Rufinamide Tablets USP
Drug Approval | August 19, 2022

Lupin receives approval from U.S. FDA for Rufinamide Tablets USP

The product will be manufactured at Lupin's facility in Goa, India.


Lupin receives approval from U.S. FDA for Meclizine Hydrochloride Tablets USP
Drug Approval | August 16, 2022

Lupin receives approval from U.S. FDA for Meclizine Hydrochloride Tablets USP

Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.


Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets
Drug Approval | July 26, 2022

Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.


U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | July 15, 2022

U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


OliX Pharmaceuticals submits application to U.S. FDA to evaluate safety and tolerability of OLX10212
Drug Approval | July 04, 2022

OliX Pharmaceuticals submits application to U.S. FDA to evaluate safety and tolerability of OLX10212

The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.


Pfizer submits new drug application to the U.S. FDA for Paxlovid
Drug Approval | July 03, 2022

Pfizer submits new drug application to the U.S. FDA for Paxlovid

Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk


U.S. FDA approves treatment to control pain in cats with osteoarthritis
Drug Approval | January 14, 2022

U.S. FDA approves treatment to control pain in cats with osteoarthritis

It is the first monoclonal antibody drug for use in any animal species


Glenmark receives U.S. FDA approval for Ryaltris
Drug Approval | January 14, 2022

Glenmark receives U.S. FDA approval for Ryaltris

The recommended daily dose for Ryaltris is 2 sprays in each nostril twice daily