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16 January, 2019 19:52 IST
Cipla receives final approval for generic Pulmicort Respules
Source: IRIS | 17 Nov, 2017, 10.16AM
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Cipla, a global pharmaceutical company, today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Budesonide Inhalation Suspension, 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL from the United States Food and Drug Administration (USFDA) to market a generic version of Astrazeneca's Pulmicort Respules.

Cipla's Budesonide Inhalation Suspension, 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL, are AN-rated generic equivalents of Astrazeneca's Pulmicort Respules® and are indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. The product is available for shipping immediately.

Pulmicort Respules® and generic equivalents had U.S. sales of approximately USD 825M for the 12-month period ending September 2017, as reported by IMS Health.

Shares of the company gained Rs 11.6, or 1.95%, to trade at Rs 605.20. The total volume of shares traded was 22,486 at the BSE (9.43 a.m., Friday).



Cipla Limited   (Q,N,C,F)*

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