Last Updated on November 19, 2021 by The Health Master
Mumbai: Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mupirocin Cream USP, 2%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bactroban Cream, 2%, of SmithKline Beecham (Cork) Ltd, Ireland (SmithKline).
Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S. aureus and S. pyogenes.
Aleor has been granted a Competitive Generic Therapies (CGT) designation for this ANDA and it is eligible for 180 days of CGT exclusivity as it is the first approved applicant.
Mupirocin Cream USP, 2% has an estimated market size of US$ 28 million for twelve months ending Jun 2021 according to IQVIA.
Alembic has received year to date (YTD) 13 approvals (10 final approvals and 3 tentative approvals) and a cumulative total of 152 ANDA approvals (133 final approvals and 19 tentative approvals) from the USFDA.
Aleor Dermaceuticals Limited had earlier received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
USFDA gives nod to Zydus Pharma for Eluxadoline Tablets
USFDA gives final nod to Zydus Cadila for Glycopyrrolate Injection
USFDA approves Drug to treat Hyperactivity disorder
USFDA’s nod for Kerala’s local herb Manathakkali for Liver Cancer Treatment
USFDA nod for Cortrophin Gel to treat Autoimmune Disorders
Allergan gets USFDA nod for eye drop to treat blurry vision
CDSCO gives nod to Cadila for the drug to treat hyperkalemia
Pharma Industry to depend on low cost Chinese APIs due to…
No retention or renewal fees after one time registration of ASU products
PCI issues further advisory to Pharmacy Colleges regarding salaries to Teachers
A woman doing illegal MTPs arrested: Haryana
International Conference on National Education Policy will be held at …
IPC adds new impurities and Reference Standards: Download the list
Drug alert: 36 out of 1061 samples declared as NSQ in October 2021
Latest Circulars by the Govt of India, Dept of Pharmaceuticals, Health…
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: