Indian pharmaceutical company Cipla has received the US Food and Drug Administration (FDA) approval for its AB-rated generic equivalent version of Novartis’ Durezol.
The US regulator has approved Cipla’s Abbreviated New Drug Application (ANDA) for Durezol (Difluprednate Ophthalmic Emulsion) 0.05%.
According to IQVIA (IMS Health), the medicine had sales of around $106m in the US for the past 12 months ending June 2021.
Durezol is a topical corticosteroid that is indicated for inflammation and pain associated with ocular surgery, and for endogenous anterior uveitis.
To treat inflammation and pain associated with ocular surgery, one drop of Durezol is administered into the conjunctival sac of the affected eye four times daily.
Treatment should start after 24 hours from the surgery and continued throughout the first two weeks of the postoperative period, followed by two times daily for a week.
For endogenous anterior uveitis, one drop is administered into the conjunctival sac of the affected eye four times daily, for 14 days followed by tapering as clinically indicated.
Durezol Emulsion is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis, vaccinia and varicella.
Also, the drug is not advised for patients with mycobacterial infection of the eye and fungal diseases of ocular structures.
The most common adverse reactions in ocular inflammation and pain studies include corneal oedema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, conjunctival oedema and blepharitis.
Also, the most common adverse reactions in the endogenous anterior uveitis studies include blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis and uveitis.
Established in 1935, Cipla is focused on agile and sustainable growth, complex generics, and strengthening portfolio in India, South Africa, North America and emerging markets.
The company has expertise in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments.
It has 46 manufacturing sites around the world that produce an excess of 50 dosage forms and above 1,500 products using advanced technology platforms.
