Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 31
Drug Approval
Drug Approval | 26 April 2022

Corbevax gets DCGI nod for Emergency Use in 5-12 years

The approval comes soon after Corbevax was given the nod for 12-15-year group

Drug Approval
Drug Approval | 26 April 2022

DCGI grants Covaxin Emergency Use Approval for children 6-12 years

Covaxin was earlier approved for children 12-18 years of age

Drug Approval
Drug Approval | 26 April 2022

ZyCoV-D two-dose vaccine receives Emergency Use Approval from DCGI

The two-dose regimen for ZyCoV-D was tested in 3100 healthy volunteers more than 12 years of age

Drug Approval
Drug Approval | 25 April 2022

Aleor Dermaceuticals receives USFDA approval for Clobestasol

Clobetasol Propionate Foam, 0.05% has an estimated market size of US $ IO million for twelve months ending Dec 2021 according to IQVIA

Drug Approval
Drug Approval | 23 April 2022

CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment

If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe

Drug Approval
Drug Approval | 21 April 2022

Saraq Hepatitis C kit receives CDSCO nod

The approval of this important test marks the 14th IVD to receive clearance by the CDSCO, and strengthens the company’s foundation for future growth

Drug Approval
Drug Approval | 21 April 2022

Dr. Reddy's launch Posaconazole delayed-release tablets in the US

The tablets are available in 100 mg strength in bottle count sizes of 60

Drug Approval
Drug Approval | 21 April 2022

Boehringer Ingelheim launches RenuTend to heal ligament injuries in horses

Targeted action improves quality of healing of tendon and suspensory ligament injuries in horses

Drug Approval
Drug Approval | 20 April 2022

Alembic Pharmaceuticals receives USFDA tentative approval for heart failure drug

Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA

Drug Approval
Drug Approval | 20 April 2022

BDR Pharmaceuticals launch Furmecil to treat advanced gastric cancer

The launch is yet another first of its kind innovation in India

Drug Approval
Drug Approval | 19 April 2022

Takeda announces approval of Nuvaxovid Covid-19 vaccine in Japan

Approval for primary and booster immunization is based on efficacy and safety data from Japan and international clinical studies

Drug Approval
Drug Approval | 18 April 2022

SonoScape receives USFDA 510(k) clearance for HD-550 Endoscopy system

The HD-550 endoscopy system has been available outside of the USA since 2019

Drug Approval
Drug Approval | 18 April 2022

Amneal achieves second U.S. biosimilars approval with Alymsys

Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022

Drug Approval
Drug Approval | 18 April 2022

Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India

Drug Approval
Drug Approval | 18 April 2022

Zydus Lifesciences receives final approval from USFDA for Cyanocobalamin Injection

The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat

Drug Approval
Drug Approval | 15 April 2022

Sandoz launches generic brimonidine tartrate eyedrop in US

Ocular hypertension affects over 5% of all adults; the eye does not properly drain fluid, causing eye pressure to build up

Drug Approval
Drug Approval | 15 April 2022

Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg

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

Drug Approval
Drug Approval | 12 April 2022

Aleor receives USFDA approval for Lidocaine and Prilocaine Cream

Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA

Drug Approval
Drug Approval | 07 April 2022

Alembic gets USFDA tentative approval for dabigatran etexilate capsules

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim

Drug Approval
Drug Approval | 07 April 2022

Lupin launches Merzee capsules in the United States

Merzee is a generic equivalent of Taytulla of Allergan Pharmaceuticals International

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