Cipla gets USFDA nod for its ANDA for nasal spray

The United States Food and Drug Administration (USFDA) has granted final approval to Cipla Limited for its Abbreviated New Drug Application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL with a Competitive Generic Therapy (CGT) designation.

Becoming the 'first approved applicant' for such CGT, Cipla is therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla's product. The commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL will not be blocked by this 180-day CGT exclusivity.

Cipla’s Dihydroergotamine Mesylate nasal spray 4mg/ml is an AB-rated generic therapeutic equivalent version of Bausch Health US LLC’s Migranal. This is Cipla’s first ANDA approval for a nasal spray. It is indicated for the acute treatment of migraine headaches with or without aura.

As per the data provided by IQVIA (IMS Health) for the 12-month period ending March 2020, Migranal and its authorised generic equivalents had US sales of approximately USD 102 million.

On Thursday, the stock of Cipla opened at Rs 620.15 against its previous close of Rs 620.35.