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Cipla bags USFDA nod for generic version of Durezol

Mumbai: Drug major, Cipla Limited, today announced that the company has received final approval for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05% from the United States Food and Drug Administration (USFDA). Cipla's Difluprednate Ophthalmic Emulsion 0.05% is AB-rated generic therapeutic equivalent version of Novartis Pharmaceutical...
Mumbai: Drug major, Cipla Limited, today announced that the company has received final approval for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05% from the United States Food and Drug Administration (USFDA).
Cipla's Difluprednate Ophthalmic Emulsion 0.05% is AB-rated generic therapeutic equivalent version of Novartis Pharmaceutical Corporation's Durezol.
It is used for the following:
• Treatment of inflammation and pain associated with ocular surgery.
• Treatment of endogenous anterior uveitis.
The product will be available for shipping soon, the company said.
According to IQVIA (IMS Health), Durezol had US sales of approximately $106mn for the 12-month period ending June 2021.
Read also: Cipla arm's oral liquid dosage, nasal product unit acquired by Rubicon Research
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai.
Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions.
M.Com
Ruchika 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