Home Insect Allergies FDA Approves Amneal’s OTC Naloxone Nasal Spray

FDA Approves Amneal’s OTC Naloxone Nasal Spray

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RT’s Three Key Takeaways:

  1. Amneal Prescribed drugs Inc has obtained FDA approval for its over-the-counter naloxone hydrochloride nasal spray, a generic equal to Narcan.
  2. The nasal spray is meant to assist deal with drug overdoses from opioids, together with heroin, fentanyl, and prescription opioid medicines, by offering emergency intervention.
  3. Amneal plans to extend its manufacturing capability to as much as 4 million two-packs by the top of 2024 and as much as 10 million by the top of 2025.

Amneal Prescribed drugs Inc introduced it obtained US Meals and Drug Administration approval for its over-the-counter naloxone hydrochloride nasal spray.

Amneal’s naloxone nasal spray, 4 mg, a generic equal to over-the-counter Narcan hydrochloride nasal spray, is meant to assist deal with drug overdose from opioids, together with heroin, fentanyl, and prescription opioid medicines.

“With right now’s launch, Amneal is proud to assist deal with this public well being emergency by offering naloxone nasal spray at an inexpensive worth and and not using a prescription. Our enterprise is deeply rooted in a dedication to serving to others. By enhancing entry to naloxone nasal spray, we hope to get this inexpensive emergency therapy into the palms of much more individuals who might probably save numerous households and communities from additional heartache and loss,” says Chirag and Chintu Patel, co-chief govt officers, in a launch.

Additional studying: FDA Approves Second OTC Naloxone Nasal Spray

Greater than two-thirds of all drug overdose fatalities in 2022 concerned illicit, artificial opioids like fentanyl, which is the offender in additional deaths below age 50 than every other trigger, together with coronary heart illness, most cancers, murder, suicide, and different accidents. In accordance with the Facilities for Illness Management and Prevention, in about 46% of overdose deaths, one other individual is current and has the potential to intervene.

The product will probably be obtainable at pharmacies. Amneal expects to have manufacturing capability of as much as 4 million two-packs by the top of 2024 and as much as 10 million by the top of 2025. The product is made in america at one in every of Amneal’s manufacturing services in New Jersey. 

Additional studying: FDA Approves Narcan Nasal Spray for OTC Use

Photograph caption: Amneal’s over-the-counter naloxone hydrochloride nasal spray, 4 mg

Photograph credit score: Amneal Prescribed drugs Inc

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