Monday, drug maker AstraZeneca (AZN, AZN.L) said the US Food and Drug Administration has asked the company for more data relating to Symbicort pressurized metered dose inhaler for the long-term maintenance treatment of asthma in children aged between 6 and 11 years.
The company received a Complete Response Letter, or CRL, from the agency stating that AstraZeneca did not provide adequate data to establish the appropriate dose or doses of the individual components of Symbicort - budesonide and formoterol. The CRL further says the data funished were not sufficient to establish how the individual components contribute to the combination product.
The company is evaluating the CRL and said it will provide a response to the agency in due course.
Symbicort was approved in the U.S. in July 2006 for the long-term maintenance treatment of asthma in patients 12 years of age and older. It was approved in February this year for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
AstraZeneca noted that the CRL has no impact on the current prescribing information for the treatment of patients taking Symbicort for these approved indications. The drug competes with GlaxoSmithKline plc's (GSK) Advair.
In 2008, AstraZeneca reported profit of $6.13 billion, up from $5.63 billion in 2007. Annual sales increased 7% to $31.60 billion from $29.56 billion in the preceding year. Symbicort sales grew 22% to $2.0 billion in 2008.
In a separate development, AstraZeneca said the Competition Authority in Sweden approved the divestment of a portfolio of its over-the-counter products to GlaxoSmithKline.
Under the agreement, announced in November 2008, AstraZeneca receives SEK 1770 million, or about $220 million, at current exchange rates. The brands being sold include analgesics Alvedon and Reliv, Nezeril/Nasin for decongestion, Minifom for gastrointestinal disorder and Duroferon for treatment of iron deficiency.
AstraZeneca said that the divestment will be reflected as other operating income in its second quarter accounts.
AZN is currently trading at $35.27, up $0.33 or 0.94%, on 314,119 shares.
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