First Generic Drug for Asthma and COPD Gets FDA Approval – Healthline

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 drug contains budesonide, a corticosteroid that helps control inflammation, and formoterol, a long-acting bronchodilator that relaxes the muscles in the airways to ease chest tightness and shortness of breath.
Used as an inhaler, Symbicort has been shown to reduce asthma and COPD episodes, hospitalizations, and deaths among people with moderate to severe asthma and COPD.
Health experts say the generic approval is exciting news for the approximately 25 million people who have asthma and 16 million who live with COPD in the United States.
Generic medications, which contain the same ingredients as brand versions, are more affordable and make it easier for people to access care and treatment.
“Cost has been a hurdle for many patients irrespective of their insurance status. Hopefully having a generic inhaler available will ease the cost burden that many patients have had to shoulder,” said Dr. Fady Youssef, a board certified pulmonologist, internist, and critical care specialist at MemorialCare Long Beach Medical Center in Long Beach, California.
Symbicort is one of the most efficacious and fastest-working asthma and COPD medications for people with poorly managed asthma symptoms, according to Dr. Puja Uppal, a board certified family medicine 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 studied in African American patients with moderate to severe asthma. It was found to lead to significant lung improvements, according to Uppal.
“This was a huge medical accomplishment given 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 version.
“Generic medications oftentimes are thought to be inferior to the brand-name medication by patients — I just want to make sure that patients understand that this isn’t the case. Generic medications contain the same ingredients as the brand-name medication,” said Dr. Payel Gupta, a board certified allergy and asthma doctor at SUNY Downstate Medical Center at Mt. Sinai Medical Center in New York City.
Generic medications are generally less expensive than the original brand, which makes the drug more accessible to people.
“Availability of generic versions typically make access to drugs easier and reduces the cost,” said Dr. Tina Sindher, an allergy and immunology physician with Stanford Medicine.
Uppal says that for years, Symbicort has been cost prohibitive.
“This translated to low levels of medication adherence, especially in vulnerable populations,” Uppal said.
Some of Uppal’s patients have taken less than the recommended daily amount to prolong the inhaler’s use.
“It’s hard to believe that many of my patients take one puff of Symbicort every other day, rather than four puffs per day because of its cost,” Uppal said.
There are many factors that go into determining the type of inhaler you should use, so it’s important to talk with your treating physician 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,” said Sindher.
If you take Symbicort and are interested in continuing with the generic version, talk with your doctor and request the change.
Many people will be able to switch to the generic version immediately. You can also ask your pharmacist about switching to the generic.
“If you’re in the middle of a prescription, your doctor or healthcare 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.
Physicians say the approval is exciting news for the millions of people who live with either asthma or COPD in the United States.
Symbicort has previously been cost prohibitive for many people, and a generic version will help many people afford and access care.
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