The drug is an inhalation aerosol that treats symptoms of two common pulmonary health conditions.
The U.S. Food and Drug Administration on Tuesday approved the first generic Symbicort drug used to treat asthma and chronic obstructive pulmonary disease , which are two common pulmonary health conditions.
The drug is an inhalation aerosol that treats asthma in patients 6-years-old and up and will treat airflow obstructions and reduce exacerbations for those with COPD. The drug will also treat chronic bronchitis and emphysema. Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research said, “Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment.
Choe said, “This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers." According to the FDA, asthma affects 25 million people, with more than 5 million of those being children. COPD affects more than 16 million people.
México Últimas Noticias, México Titulares
Similar News:También puedes leer noticias similares a ésta que hemos recopilado de otras fuentes de noticias.
How the FDA bungled the powdered infant formula recallA manufacturing plant that produced baby formula had a long history of safety regulation violations. Yet it remained open, and it was only after a baby died that the company issued a recall.
Leer más »
Pfizer CEO says fourth dose of COVID vaccine is 'necessary,' submits data to FDACEO Albert Bourla said the vaccine remains protective against hospitalizations and deaths, but 'doesn't last very long' for warding off infections.
Leer más »
3 COVID-19 tests recalled after FDA warns about ‘high risk’ of false resultsLuSys Laboratories issued the recall this week for three of its COVID-19 tests. The FDA believes they were distributed for use in laboratories and for at-home testing.
Leer más »
Pfizer/BioNTech seek FDA authorization for fourth Covid-19 vaccine doses for people 65 and upPfizer and BioNTech submitted an application for emergency use authorization to the US Food and Drug Administration for an additional booster dose of their Covid-19 vaccine for adults 65 and older who have gotten a booster dose of any of the authorized or approved vaccine, the companies said Tuesday.
Leer más »
If You Have This COVID Test at Home, Throw It Out Immediately, FDA Warns — Best LifeACON Laboratories, manufacturer of Flowflex COVID antigen home tests, has discovered unauthorized and potentially dangerous distribution.
Leer más »