Requests FDA to (i) require proposed generic versions of Intranasal (IN) naloxone products to provide specific pharmacokinetic (PK), device, stability and Chemistry, Manufacturing and Controls (CMC) data, as set-out herein, within the ANDA, to support the interchangeability of generic IN naloxone and the IN naloxone Reference Listed Drug (RLD); (ii) not to approve any generic
Citizen Petition CDER OPEN 2016-6743 Adapt Pharms Operations Ltd Intranasal (IN) naloxone products pharmacokinetic (PK) device, stability and Chemistry Manufacturing and Controls (CMC) data interchangeability of generic IN naloxone Reference Listed Drug (RLD) generic application
2017-05-15 2017-05-05
FDA-2016-P-3912-0005 FDA-2016-P-3912-0004
04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2016-P-3912-0005 https://api.regulations.gov/v4/comments/FDA-2016-P-3912-0004
Anonymous Anonymous
Anonymous Anonymous
Please keep in mind that there are legit chronic pain patients whom have tried everything with no success. The only relief for somepatients is being on Narcotic medication. Not everyone that takes medications are so called druggies.  There are plenty of patients thatsuffer 24/7 and without the medications that they take there life is worthless. some chronic pain patients cannot get out of beddue to them hurting until they take there medications and feel better. No one wants to be in pain and why should the FDA or theDEA make them suffer when there are medications that help?  This makes NO sense at all. We live in the U.S. and we are suppose tolive in a free Country, however, each day it seems like we are loosing our rights. FDA-2017-N-1847.Subject: Please preserve compounding substances.Pharmacy Compounding Advisory Committee,I urge the FDAs PCAC to preserve consumer access to important compounded ingredients. The substances being considered at the May meeting have been used for a long time and have demonstrated safety records. There may be commercial formulations of these substances, but the role of compounding pharmacies is to provide patients with special needs the medicines they require. Some people have environmental sensitivities and cannot have preservatives in their medicines; some have gluten intolerance and cannot have gluten in a pill; others, such as elderly patients and autistic patients, have difficulty swallowing pills. Compounding pharmacies can make special preparations for these patients. Heres whats at stake: Artemisinin is a compound found in sweet wormwood, an herb that has been used in traditional Chinese medicine for centuries. It is most notably used to treat malaria, but it may also be helpful for tuberculosis and a host of other conditions. Considering the rise of drug-resistant TB, which is virtually untreatable and is sending conventional doctors into a panic, it would be lunacy to restrict access to this herb. Ubiquinol is by far the most effective, bioavailable form of CoQ10. Some people may not be able to convert the ubiquinone form of CoQ10 into ubiquinol, which means access to ubiquinol products is extremely important. CoQ10 / ubiquinol has many benefitsit is used for energy production by every cell in the body. It is especially useful for patients on statins since these drugs deplete the body of CoQ10. Nettle has a number of salutary effects. It was used by Roman soldiers to withstand the cold by stimulating blood circulation. It helps the body detoxify itself, alleviates allergic reactions, and promotes healthy blood circulation. Vanadyl sulfate is an insulin mimic and a natural therapy for diabetes and insulin resistance. It is a form of a trace mineral found in mushrooms and shellfish.  Nicotinamide adenine dinucleotide (NAD) is a vital compound involved in mitochondrial health and energy metabolism. As NAD levels decline later in life, mitochondrial function is impaired, resulting in various symptoms of aging. NAD is also an essential cofactor of certain key enzymes that are responsible for longevity. Every year we are learning more about how critical NAD is, including for cancer control. Please do not further restrict the medicines that compounding pharmacies can make for their customers. The ability of compounding pharmacies to function, thrive, and produce these crucial supplements plays a crucial role in peoples lives.Ron Rattner1998 Broadway Apt 1204San Francisco, CA 94109