Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 6

Results For "reference-listed-drug-product"

81 News Found

Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets
Drug Approval | May 24, 2022

Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets

The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA


Alembic Pharmaceuticals receives USFDA  approval for Arformoterol Tartrate
Drug Approval | May 11, 2022

Alembic Pharmaceuticals receives USFDA approval for Arformoterol Tartrate

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies


Aleor Dermaceuticals receives USFDA approval for Docosanol Cream
Drug Approval | May 04, 2022

Aleor Dermaceuticals receives USFDA approval for Docosanol Cream

Docosanol Cream, 10% (OTC) has an estimated market size of US$60 million for twelve months ending December 2021 according to IQVIA


Aleor Dermaceuticals receives USFDA approval for Clobestasol
Drug Approval | April 25, 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


Alembic Pharmaceuticals receives USFDA tentative approval for heart failure drug
Drug Approval | April 20, 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


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


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


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


Alembic receives USFDA tentative approval for hypertension drug
Drug Approval | March 14, 2022

Alembic receives USFDA tentative approval for hypertension drug

Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA


Aleor Dermaceuticals receives USFDA approval for Nystatin and Triamcinolone Acetonide ointment
Drug Approval | March 08, 2022

Aleor Dermaceuticals receives USFDA approval for Nystatin and Triamcinolone Acetonide ointment

Nystatin and Triamcinolone Acetonide ointment is indicated for the treatment of cutaneous candidiasis