- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Alembic Pharma gets USFDA nod to Timolol Maleate Ophthalmic Gel Forming Solution
Timolol Maleate Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Timoptic-XE...
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Timoptic-XE Ophthalmic Gel Forming Solution, 0.25% and 0.5%, of Bausch Health US, LLC.
Timolol Maleate Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Alembic 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 ANDA.
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% has an estimated market size of US$ 71 million for twelve months ending June 2020 according to IQVIA.
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Pvt Ltd. Alembic has a cumulative total of 134 ANDA approvals (117 final approvals and 17 tentative approvals) from USFDA.
Read also: Alembic Pharma JV Aleor Derma gets USFDA nod for Tavaborole Topical Solution
Alembic Pharmaceuticals Limited, 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.
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751