FDA issues new and revised product specific guidances for five nasal sprays

The FDA has issued a new product-specific guidance for dihydroergotamine mesylate nasal spray and revised guidances for fluticasone propionate; azelastine hydrochloride/fluticasone propionate; mometasone furoate; and triamcinolone acetonide nasal sprays since February 1, 2019.

According to the agency, the latest batch of guidances issued includes a total of 74 drugs, with 49 of those being complex drugs. FDA Commissioner Scott Gottlieb said, “As the FDA works to help promote drug competition and patient access to affordable medicines, our efforts have been especially focused on complex drugs, which may be harder to genericize and often face less competition. In 2019, the agency will continue to advance policies to help promote competition in this space and help to reduce development time for complex generics.”

Guidances for mometasone furoate, fluticasone propionate and azelastine HCL/fluticasone propionate were issued in 2015. The previous guidance for triamcinonolone acetonide nasal spray was released in 2016.

Read News Reported By: OINDPnews

Read the FDA announcement.
View the guidance on DHE nasal spray.
View the guidance on fluticasone propionate nasal spray.
View the guidance on azelastine hydrochloride/fluticasone propionate nasal spray.
View the guidance on mometasone furoate nasal spray.
View the guidance on triamcinolone acetonide nasal spray.

ARS Pharmaceuticals Announces FDA Fast Track Designation for ARS-1 Intranasal Epinephrine Spray

ARS Pharmaceuticals, Inc., a pharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions potentially leading to anaphylaxis, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ARS-1, an investigational intranasal epinephrine spray that could provide an easy-to-use, convenient and more reliable treatment for severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis.

“The FDA’s decision to grant Fast Track Designation for our novel intranasal epinephrine spray is an important milestone in our mission to deliver a reliable needle-free treatment option that is easier to carry and use for the emergency treatment of severe allergic reactions that could lead to anaphylaxis,” said Richard Lowenthal, President and Chief Executive Officer of ARS Pharmaceuticals. “Fast Track Designation is an acknowledgement from the FDA of the potential contribution of our low dose intranasal epinephrine product for patients and caregivers, and we look forward to advancing the development of ARS-1 so it is available to the community as soon as possible.”

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FDA Advisory Committee Recommends Approval of SPRAVATO™ (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression

If approved, SPRAVATO™ will offer the first new mechanism of action in 30 years to treat this debilitating disease, continuing Janssen’s 60-plus-year history and commitment to research that make a difference for people living with mental illnesses, including severe mood disorders

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted (14 yes, 2 no, 1 abstain) that data support the favorable benefit-risk profile of SPRAVATOTM (esketamine) nasal spray CIII for adults living with treatment-resistant depression. SPRAVATOTM is an investigational prescription treatment that is thought to work differently than currently approved therapies for major depressive disorder (MDD). Janssen announced on September 4, 2018 that it submitted a New Drug Application (NDA) to the FDA for the approval of SPRAVATOTM.1 If approved, SPRAVATOTM would provide the first new mechanism of action in 30 years to treat this debilitating mental illness.

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