Last Updated on December 31, 2023 by The Health Master
Alembic Pharmaceuticals today announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram.
The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD) Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 U/g/0.1 per cent, of Taro Pharmaceuticals, Alembic Pharma notified in a statement.
The statement further said that Nystatin and Triamcinolone Acetonide Ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
Nystatin and Triamcinolone Acetonide Ointment has an estimated market size of $4 million for twelve months ending Dec 2021 according to IQVIA, added the statement.
USFDA approves expanded use of cancer drug Opdivo
USFDA gives nod to Lupin for generic Jublia topical solution
USFDA gives nod to Lupin for Sevelamer Hydrochloride Tablets, 800 mg
USFDA approves this drug for bone marrow cancer treatment
USFDA gives nod to Unichem Laboratories for Divalproex Sodium
USFDA approves this drug for all heart patients to cut death, hospitalization risk
ICMR in collaboration with pharma companies to develop Dengue vaccine
DCGI gives nod to Zydus Oxemia to treat anaemia
Pfizer recalls this BP drug on potential cancer-causing impurity
Phase-3 Clinical Trial permission of Covovax as booster dose recommended
NPPA fixes retail price of Normal Human Immunoglobulin 5% Solution
Clarification sought from CDSCO on approval status of Clotrimazole 1% mouth paint
Govt recommends imposition of anti-dumping duty on import of Dicyclohexylcarbodiimide from China
USFDA approves expanded use of cancer drug Opdivo
Govt releases draft Unani Pharmacopoeia of India
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:
