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7944 News Found

Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP
News | August 06, 2024

Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP

Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity


Gland Pharma receives USFDA’s tentative approval for Latanoprostene Bunod Ophthalmic Solution
Drug Approval | July 24, 2024

Gland Pharma receives USFDA’s tentative approval for Latanoprostene Bunod Ophthalmic Solution

The product is bioequivalent and therapeutically equivalent to the reference listed drug


Lupin and Huons Sign agreement for commercialization of cyclosporine ophthalmic nanoemulsion in Mexico
News | July 22, 2024

Lupin and Huons Sign agreement for commercialization of cyclosporine ophthalmic nanoemulsion in Mexico

Cyclosporine Ophthalmic Nanoemulsion is a preservative-free Nanoemulsion that has been approved in South Korea, Peru and several countries in the Middle East for treatment of dry eye syndrome


AbbVie appoints Roopal Thakkar as EVP, Research & Development and Chief Scientific Officer
People | July 10, 2024

AbbVie appoints Roopal Thakkar as EVP, Research & Development and Chief Scientific Officer

Dr. Roopal Thakkar joined Abbott/AbbVie in 2003 as part of the Physician Development Program


Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
Drug Approval | July 10, 2024

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product


Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets
Drug Approval | June 14, 2024

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of US$ 77.9 mn in the United States (IQVIA MAT March 24).


Glenmark receives ANDA approval for Brimonidine Tartrate and Timolol Maleate ophthalmic solution
Drug Approval | May 18, 2024

Glenmark receives ANDA approval for Brimonidine Tartrate and Timolol Maleate ophthalmic solution

According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market achieved annual sales of approximately $290.0 million


Zydus receives final approval from USFDA for Dexamethasone Tablets
Drug Approval | May 13, 2024

Zydus receives final approval from USFDA for Dexamethasone Tablets

Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)


Lupin receives USFDA approval for travoprost ophthalmic solution
Drug Approval | May 07, 2024

Lupin receives USFDA approval for travoprost ophthalmic solution

Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.