Timolol Maleate

The eyedrop is an option for those who are benefitting from preservative-free eye drops. Credit: Andrey Sayfutdinov/Shutterstock. China’s National Medical Products Administration (NMPA) has approved the marketing authorisation application of Santen Pharmaceutical’s Tapcom to treat individuals with open-angle glaucoma or ocular hypertension. This fixed-combination eye drop comprising tafluprost 0.0015% and timolol 0.5% is designed to lower intraocular pressure (IOP) for individuals with this condition. Glaucoma damages the optic nerve and results in visual field loss. The eye drop offers a therapeutic alternative for individuals whose topical beta-blockers or prostaglandin derivatives monotherapies have not achieved target IOP. It is also an option for those who are benefitting from preservative-free eye drops in prolonged topical usage of glaucoma medication. Tapcom is the country’s first preservative-free ophthalmic combo formulation to include a first-line prostaglandin derivative. Its two active ingredients, tafluprost and timolol maleate, work through different mechanisms to reduce IOP. Tafluprost acid, the active metabolite of tafluprost, is a prostanoid FP receptor agonist that promotes aqueous humour outflow. A nonselective β-receptor inhibitor, timolol maleate, decreases the production of aqueous humour. Tapcom has gained approval in 40 countries and regions, including Asia and Europe. Santen Pharmaceutical chief medical officer Peter Sallstig stated: “Glaucoma remains the leading cause of irreversible blindness worldwide, deeply impacting the quality of life of many patients. “Therefore, Santen has prioritised glaucoma as a key therapeutic focus, dedicating ourselves to the development of treatments that meet patients’ needs and the delivery of high-quality ophthalmic drugs. The approval of Tapcom in China represents a significant milestone, offering new treatment options for Chinese glaucoma patients and advancing the field of glaucoma care.” In November 2024, the company and Arctic Vision signed a commercial partnership agreement for the ARVN001 suprachoroidal injectable suspension for uveitic macular oedema and other ocular conditions.

New Delhi: Drug firms Glenmark Pharmaceuticals and FDC Ltd are recalling products in the US market due to manufacturing issues , according to the US Food and Drug Administration ( USFDA ). In its latest Enforcement Report, the US health regulator said a US-based subsidiary of Mumbai-headquartered Glenmark Pharmaceuticals is recalling a certain number of a generic hypertension medication in the US market. New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling Carvediol tablets in strengths of 25 mg and 12.5 mg in the US, the US health regulator stated. The company is recalling the product as "N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit". The company initiated the Class II recall on January 22 this year. USFDA said FDC Ltd is recalling 1,18,104 bottles of a medication for the treatment of glaucoma. The drug firm is recalling the affected lot of Timolol Maleate ophthalmic solution USP produced at its Aurangabad-based plant, it added. The recall is due to a "Defective Container", the USFDA stated. "Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle," it added. The company initiated the Class II recall on January 23, 2025. As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.