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Lonhala Magnair Approval History

  • FDA approved: Yes (First approved December 5th, 2017)
  • Brand name: Lonhala Magnair
  • Generic name: glycopyrrolate
  • Dosage form: Inhalation Solution
  • Company: Sunovion Pharmaceuticals Inc.
  • Treatment for: COPD

Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

IMPORTANT SAFETY INFORMATION

Lonhala Magnair does not relieve sudden symptoms of COPD and should not be used more than twice daily. Always have a short-acting beta2-agonist with you to treat sudden symptoms.

Do not use Lonhala Magnair unless your health care provider has taught you how to use the device and you understand how to use it correctly. Use Lonhala Magnair exactly as your health care provider tells you to use it.

Do not use Lonhala Magnair more often than is prescribed for you. Do not stop using Lonhala Magnair or other medicines to control or treat your COPD unless told to do so by your health care provider because your symptoms might get worse. Your health care provider will change your medicines as needed.

Get emergency medical care if your breathing problems worsen quickly, you need to use your rescue medication more often than usual, or your rescue medication does not work as well to relieve your symptoms.

Do not use Lonhala Magnair if you are allergic to glycopyrrolate or to any of the ingredients in Lonhala Magnair. Ask your health care provider if you are not sure.

Tell your health care provider about all of your health conditions, including if you:

  • have kidney problems
  • have eye problems such as glaucoma
  • have prostate or bladder problems, or problems passing urine
  • have any other medical conditions
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed
  • are allergic to Lonhala Magnair or any of its ingredients, or to any other medicines or food products

Tell your health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Lonhala Magnair and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your health care provider if you take anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate).

Lonhala Magnair side effects

Lonhala Magnair can cause serious side effects, including:

  • sudden shortness of breath (that may be life-threatening) immediately after use of Lonhala Magnair
  • serious allergic reactions, including: rash; hives; swelling of the tongue, lips, and face; and difficulty breathing or swallowing. Call your health care provider or get emergency medical care if you get any symptoms of a serious allergic reaction
  • new or worsened eye problems, including acute narrow-angle glaucoma (symptoms may include eye pain or discomfort, blurred vision, red eyes, nausea or vomiting, seeing halos or bright colors around lights)
  • new or worsened urinary retention (symptoms may include difficulty urinating, urinating frequently, painful urination, urination in a weak stream or drips)

Common side effects include shortness of breath and urinary tract infection.

These are not all of the possible side effects. Tell your health care provider about any side effect that bothers you or that does not go away.

Lonhala solution is for oral inhalation only and should not be injected or swallowed. Lonhala vials should only be administered with Magnair.

Development History and FDA Approval Process for Lonhala Magnair

DateArticle
Dec  5, 2017Approval Sunovion Receives FDA Approval for Lonhala Magnair (glycopyrrolate) Inhalation Solution to Treat COPD
Jun 30, 2017Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for SUN-101/eFlow® (glycopyrrolate) for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
May 26, 2017Sunovion Receives Complete Response Letter from FDA for SUN-101/eFlow® (glycopyrrolate) New Drug Application for Chronic Obstructive Pulmonary Disease (COPD)
Oct 13, 2016Sunovion Announces FDA Filing Acceptance of New Drug Application for SUN-101/eFlow® for the Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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