Alembic JV Aleor Derma gets USFDA nod for therapeutic equivalent of Clobex Spray
Clobetasol Propionate Spray, 0.05% is indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. The product is therapeutically equivalent to the reference listed drug product (RLD), Clobex Spray, 0.05% of Galderma Laboratories L.P. (Galderma), Alembic Pharma said.
New Delhi: Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received approval from - the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Spray, 0.05%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Clobex Spray, 0.05% of Galderma Laboratories L.P. (Galderma).
Also Read: Alembic Pharma JV Aleor gets USFDA nod for Clobetasol Propionate ointment
Clobetasol Propionate Spray, 0.05% is indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.
Clobetasol Propionate Spray, 0.05%, has an estimated market size of US$ 22 million for twelve months ending December 2018 according to IQVIA.
Alembic has a cumulative total of 103 ANDA approvals (91 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals Ltd. is headquartered in Vadodara city of Gujarat. The company is involved in the manufacture of pharmaceutical products, pharmaceutical substances and intermediates. It is also termed to be a market leader in macrolides segment of anti-infective drugs in India.
Also Read: Alembic Pharma gets USFDA nod for Acetazolamide extended-release capsules
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd