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Results For "New-Drug-Application"

372 News Found

Zydus to supply Sagent's caffeine citrate oral solution from Jarod
Biotech | April 13, 2022

Zydus to supply Sagent's caffeine citrate oral solution from Jarod

This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants


Aleor receives USFDA approval for Lidocaine and Prilocaine Cream
Drug Approval | April 12, 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


Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer
Biotech | April 08, 2022

Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer

The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC


Alembic gets USFDA tentative approval for dabigatran etexilate capsules
Drug Approval | April 07, 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


USFDA clears IND application for an intranasal RSV vaccine
Biotech | March 29, 2022

USFDA clears IND application for an intranasal RSV vaccine

The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers


Tarlige tablets approved in Japan for treatment of patients with neuropathic pain
Drug Approval | March 28, 2022

Tarlige tablets approved in Japan for treatment of patients with neuropathic pain

In May 2021, Daiichi Sankyo had submitted a supplemental new drug application (sNDA) for Tarlige tablets based on results from a phase 3 trial in patients with CNP


Japan approves BMS’ Breyanzi application for relapsed large B-cell lymphoma
Drug Approval | March 25, 2022

Japan approves BMS’ Breyanzi application for relapsed large B-cell lymphoma

This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan


Lupin receives approval from USFDA for Sildenafil for Oral Suspension
Drug Approval | March 24, 2022

Lupin receives approval from USFDA for Sildenafil for Oral Suspension

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


Alembic Pharmaceuticals receives USFDA approval for Lacosamide tablets
Drug Approval | March 21, 2022

Alembic Pharmaceuticals receives USFDA approval for Lacosamide tablets

The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older


Jubilant Pharmova arm receives ANDA approval for psychoneurosis drug
Drug Approval | March 19, 2022

Jubilant Pharmova arm receives ANDA approval for psychoneurosis drug

The generic version of Sinequan, which is used for the treatment of anxiety, depression, and other target symptoms of psychoneurosis