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Authorized Generic for Dymista

The Authorized Generic for Dymista® is the same formulation (combination azelastine hydrochloride and fluticasone propionate) nasal spray as the brand delivered in same vehicle.



Did You Know?

The term “authorized generic” drug is most commonly used to describe an approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product. An authorized generic may be marketed by the brand name drug company, or another company with the brand company’s permission. In some cases, even though it is the same as the brand name product, a company may choose to sell the authorized generic at a lower cost than the brand name drug. Because an authorized generic drug is marketed under the brand name drug’s New Drug Application (NDA), it is not listed in FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). While a separate NDA is not required for marketing an authorized generic, FDA requires that the NDA holder notify the FDA if it markets an authorized generic.1

 

Reference: 1. FDA List of Authorized Generic Drugs. Available at: https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs. Accessed on: 11 March 2020.

More IMPORTANT SAFETY INFORMATION (the following information applies to both DYMISTA and its Authorized Generic)

  • Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking DYMISTA.
  • Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with DYMISTA because further decreased alertness and impairment of CNS performance may occur.
  • Epistaxis, nasal ulcerations, nasal septal perforation, impaired wound healing, Candida albicans infection: Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
  • Glaucoma or posterior subcapsular cataracts: Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
  • Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections.
  • Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue DYMISTA slowly.
  • Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving DYMISTA.
  • Potent inhibitors of cytochrome P450 (CYP) 3A4: May increase blood levels of fluticasone propionate.
  • Ritonavir: Coadministration is not recommended.
  • Other potent CYP3A4 inhibitors, such as ketoconazole: use caution with coadministration.
  • The most common adverse reaction (≥2% incidence) are dysgeusia, epistaxis, and headache.

INDICATIONS (the following information applies to both DYMISTA and its Authorized Generic)

DYMISTA contains an H1-receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptom relief.

For additional information please contact us at 800-395-3376.

Click here for Full Prescribing Information for DYMISTA
Click here for Full Prescribing Information for the Authorized Generic for DYMISTA

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