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
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
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
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim
The amalgamation will integrate business operations and provide impetus to the existing portfolio of Alembic
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA
The tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency
Clarithromycin tablets USP, 250 mg and 500 mg have an estimated market size of US $ 11 million for twelve months ending September 2021 according to IQVIA
Dronedarone tablets USP, 400 mg have an estimated market size of US $ 500 million for twelve months ending September 2021 according to IQVIA
Entacapone tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021, according to IQVIA
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