Alembic Pharma receives USFDA Final Approval for Entacapone Tablets USP, 200 mg
Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Entacapone Tablets USP, 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Comtan Tablets, 200 mg, of Orion Corporation. Entacapone Tablets...
Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Entacapone Tablets USP, 200 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Comtan Tablets, 200 mg, of Orion Corporation. Entacapone Tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease.
Also Read:Alembic Pharma Doxycycline Hyclate Delayed-Release Tablets get USFDA okay
Entacapone Tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021 according to IQVIA.
Alembic has received year to date (YTD) 17 approvals (13 final approvals and 4 tentative approvals) and a cumulative total of 156 ANDA approvals (136 final approvals and 20 tentative approvals) from USFDA.
Also Read:FDA approves high-tech sound wave surgery for common Parkinson's symptoms
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/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd