First Generic Drug for Asthma and COPD Gains FDA Approval

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  • The FDA has approved the generic version of the drug Symbicort.
  • The drug is commonly used to treat asthma and COPD.
  • Health experts say the approval is exciting for the approximately 25 million people with asthma and 16 million people with COPD in the United States.

The Food and Drug Administration (FDA) has approved the generic version of a drug, Symbicort, commonly used to treat asthma and chronic obstructive pulmonary disease (COPD).

The medicine contains budesonide, a corticosteroid that helps control inflammation, and formoterol, a long-acting bronchodilator that relaxes muscles in the airways to relieve chest tightness and shortness of breath.

Used as an inhaler, Symbicort has been shown to reduce asthma and COPD episodes, hospitalizations and deaths in people with moderate to severe asthma and COPD.

Health experts say generic approval is great news for the approximately 25 million people with asthma and 16 million people with COPD in the United States.

Generic drugs, which contain the same ingredients as branded versions, are more affordable and facilitate access to care and treatment.

“Cost has been a barrier for many patients, regardless of their insurance status. Hopefully, the availability of a generic inhaler will ease the financial burden many patients have had to shoulder,” said Dr. Fady Youssef, board-certified pulmonologist, internist, and critical care specialist at MemorialCare Long Beach Medical Center in Long Beach, Calif. .

Symbicort is one of the most effective and fast-acting asthma and COPD medications for people with poorly managed asthma symptoms, according to Dr. Puja Uppal, board-certified family physician and founder of Think Healthy Doctor.

It is inhaled twice a day and is available in varying doses.

The drug was also one of the first of its kind to be studied in African-American patients with moderate to severe asthma. This has been found to lead to significant lung improvements, according to Uppal.

“This was a huge medical achievement considering the higher levels of asthma morbidity and mortality seen in the African American patient population,” Uppal said.

The generic version of the drug contains the same ingredients as the brand name version.

“Patients often think generic drugs are inferior to brand name drugs — I just want to make sure patients understand that’s not the case. Generic drugs contain the same ingredients as brand name drugs,” said Dr. Payel Gupta, an allergy and asthma physician at SUNY Downstate Medical Center at Mt. Sinai Medical Center in New York City.

Generic drugs are usually less expensive than the original brand, which makes the drug more accessible to people.

“The availability of generic versions generally makes drugs easier to access and lowers costs,” said Dr. Tina Sindher, an allergy and immunology physician at Stanford Medicine.

Uppal says that for years Symbicort was prohibitively expensive.

“This translated into low levels of medication adherence, especially in vulnerable populations,” Uppal said.

Some of Uppal’s patients took less than the recommended daily amount to prolong inhaler use.

“It’s hard to believe that many of my patients take one puff of Symbicort every other day, rather than four puffs a day, because of the cost,” Uppal said.

Many factors go into determining the type of inhaler you should use, so it’s important to talk to your doctor about which treatment is right for you.

“As with all medications, patients should be aware of side effects. The side effects associated with the brand name will also be associated with the generic formulation,” Sindher said.

If you are taking Symbicort and want to continue with the generic version, talk to your doctor and ask for the switch.

Many people will be able to upgrade immediately to the generic version. You can also ask your pharmacist to switch to the generic.

“If you’re in the middle of a prescription, your doctor or health care provider will need to write a new prescription,” Uppal said.

The FDA has approved the generic version of Symbicort, an inhaler used to treat asthma and COPD.

Doctors say the approval is exciting news for the millions of people living with asthma or COPD in the United States.

Symbicort was previously prohibitively expensive for many people, and a generic version will help many people afford and access care.


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