Last Updated on October 15, 2024 by The Health Master
Alembic Pharmaceuticals today announced that it has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Macitentan tablets, 10 mg.
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Opsumit tablets, 10 mg, of Actelion Pharmaceuticals US, Inc, a company statement notified.
Macitentan tablets are an Endothelin Receptor Antagonist (ERA) indicated for the treatment of Pulmonary Arterial Hypertension (PAH, WHO Group I) to delay disease progression.
Disease progression included death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased six-minute walk distance, worsened PAH symptoms and need for additional PAH treatment).
Macitentan tablets also reduced hospitalisation for PAH.
It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses, it said.
Macitentan tablets, 10 mg have an estimated market size of $797 million for twelve months ending Decemeber 2021, according to IQVIA, the statement concluded.
USFDA gives final nod to Zydus for Colestipol Hydrochloride tablets
USFDA gives nod to Strides Pharma for Colchicine tablets
USFDA gives nod to Alembic Pharmaceuticals for anti fungal drug
USFDA gives nod to Aleor for Nystatin and Triamcinolone Acetonide Ointment
USFDA approves expanded use of cancer drug Opdivo
USFDA gives nod to Lupin for generic Jublia topical solution
Govt releases draft National Medical Device Policy 2022
Deadline extended for proposals under PLI scheme for Bulk Drugs
USFDA gives final nod to Zydus for Colestipol Hydrochloride tablets
Orders to close these 5 Pharmaceutical units
USFDA inspections back in full swing for Pharma Companies
Drug recall: Macleods recalls products for these manufacturing issues
NITI Aayog to expand ‘Medicines from the Sky’ project
Make Pharma Companies liable for bribing doctors: PIL
USFDA issues 3 observations on Zydus manufacturing unit
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
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:
