Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 52
Drug Approval
Drug Approval | 20 January 2022

Zydus receives final approval from USFDA for Vigabatrin tablets

Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain

Drug Approval
Drug Approval | 20 January 2022

VFMCRP receives EU approval for Tavneos for the treatment of ANCA-associated vasculitis

First launches expected in H1 2022

Drug Approval
Drug Approval | 20 January 2022

Novo Nordisk India launches world’s first and only GLP-1 RA, oral semaglutide

Oral semaglutide is a co-formulation of GLP-1RA semaglutide with an absorption enhancer SNAC which protects semaglutide from undergoing degradation in the stomach

Drug Approval
Drug Approval | 17 January 2022

Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection

The company has 47 ANDA's pending approval with the U.S.FDA

Drug Approval
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

Drug Approval
Drug Approval | 14 January 2022

WHO recommends two new drugs for COVID-19

Their strong recommendation is based on moderate certainty evidence that it improves survival and reduces the need for ventilation

Drug Approval
Drug Approval | 14 January 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

Drug Approval
Drug Approval | 14 January 2022

Glenmark receives U.S. FDA approval for Ryaltris

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

Drug Approval
Drug Approval | 13 January 2022

South Korea approves Novavax Covid-19 vaccine

Nuvaxovid is the first protein-based Covid-19 vaccine granted approval in South Korea

Drug Approval
Drug Approval | 12 January 2022

Marksons Pharma receive final US. FDA approval for Cetirizine Hydrochloride tablets

The product will be marketed under store brand labels and is comparable to the brand Zyrtec

Drug Approval
Drug Approval | 10 January 2022

Alembic receives tentative U.S.FDA approval for dronedarone tablets

Dronedarone tablets USP, 400 mg have an estimated market size of US $ 500 million for twelve months ending September 2021 according to IQVIA

Drug Approval
Drug Approval | 06 January 2022

U.S. FDA grants approval for Alembic’s Parkinson’s drug

Entacapone tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021, according to IQVIA

Drug Approval
Drug Approval | 04 January 2022

Alembic receives USFDA approval for Doxycycline Hyclate

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

Drug Approval
Drug Approval | 03 January 2022

Emcure to launch oral Covid-19 drug soon

A toll-free helpline to be set up to help doctors and patients

Drug Approval
Drug Approval | 30 December 2021

Granules receives ANDA approval for amphetamine mixed salts

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

Drug Approval
Drug Approval | 29 December 2021

U.S. FDA approves Leo Pharma’s Adbry

Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022

Drug Approval
Drug Approval | 29 December 2021

JB Chemicals and Pharmaceuticals to launch molnupiravir next month

It will be marketed under the brand name Molunamax

Drug Approval
Drug Approval | 28 December 2021

Granules Inc., receives ANDA approval for prazosin hydrochloride

The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health

Drug Approval
Drug Approval | 28 December 2021

Cipla receives EUA for Cipmolnu

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

Drug Approval
Drug Approval | 28 December 2021

Sun Pharma receives DCGI approval for Molxvir in India

The product is expected to be available in a week’s time

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