fda approval for sitagliptin with insulin

I am curious has anybody with diabetes 1 or 2 know anything about a company called mannkind. Mannkind is in the approval process for a inhaled insulin called afrezza which is taken with a inhaler.

For people with 1b Sovaldi and Riba seems to be the ticket. Later this year the FDA should approve the companion drug for Sovaldi and do away with the Riba. Do you know what your IL28B Polymorphism is? You could wait until later this year and do the 2 drug combo or do Sovaldi and riba now.

The advisory panel voted unanimously for approval yesterday. The FDA meeting is in few weeks.

Merck has started to start applying; "We are excited by the results of these pivotal studies," said Dr. Peter S. Kim, Ph.D., president, Merck Research Laboratories. "In these studies, boceprevir substantially increased success rates compared to standard therapy, both for patients who received 48 weeks of treatment and for patients treated with the response-guided therapy approach, many of whom were able to be treated for 28 to 36 weeks," he added.

Update. The medication was FDA approved recently and will be available next year. http://www.medscape.com/viewarticle/731619 " FDA Approves Once-Daily Lurasidone for Schizophrenia Yael Waknine October 29, 2010 — The US Food and Drug Administration (FDA) has approved the atypical antipsychotic lurasidone (Latuda tablets; Sunovion Pharmaceuticals Inc) for the once-daily treatment of patients with schizophrenia...

Priority Review status can apply both to drugs that are used to treat serious diseases and to drugs for less serious illnesses. The FDA goal for reviewing a drug with Priority Review status is six months. The distinction between priority and standard review times is that additional FDA attention and resources will be directed to drugs that have the potential to provide significant advances in treatment.

Thank you for your response, I did have my bloodwork done, thyroid was fine, cholestrol a little high, estrogen low(so that could be the culprit,) no mention of diabetes or insulin resistance, but I will look into this further. Thank you, and have a great week!

I know Vertex has hired sales reps in anticipation of it being approved. FDA has 45 days starting 11/23 to decide on fast track approval 6mo or reg approval 10 months. Not sure if that's business days or calendar days. But should be coming up. The study results as so good it's hard to imagine delaying approval to market as that one guy said. I will be sure to ask my doc about how fast it will be available to order once approved.

The company (Gilead) expects only one more FDA approval this year, for one of its HIV treatments in hepatitis B, on top of three other approvals so far." Full article: http://www.bloomberg.com/gadfly/articles/2016-07-26/gilead-earnings-gliding-s-not-enough?cmpid=yhoo.

For example, when a patient is proven to be so severely ill that he cannot wait for drug approval, how does the FDA and the manufacturer know for sure if the toxcity of the drug is due to the drug or the severe illness of the patient? It is possible that the drug would be perfectly safe for a Stage 2 patient but not a patient with late Stage 4. In the drug companies eyes, this is not in their best interest when they want to get a drug approved.

Food and Drug Administration (FDA) voted unanimously to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis C. The Committee recommended by a vote of 18-0 the approval of telaprevir for those who were not treated previously and those who were treated previously but not cured with currently available medicines. Telaprevir was studied in all major subgroups of people who were treated previously and not cured: relapsers, partial responders and null responders.

I was offered to apply for the study, but I am going to wait for the approval from the FDA.

"The drug company says that with the FDA approval on their favor, Boceprevir will be shipped to pharmacies within a week. Also the company is making use of resources that include couposn to help eligible patients with cost of medication, compensation support to aid patients comprehend their insurance coverage for Boceprevir and also 24/7 nurse support through phone". Although they spelled coupons wrong (after all, they are only scientists), here is the link... http://www.

Vertex asked for fast track status several years ago. The FDA made them add another trial. The point I was trying to make along with the article is that the FDA approval process STINKS and cost many people their lives! If a drug is proven safe and tested then there is no reason you should have to wait 8-10 years to be approved. All this does is make the drugs cost more money.

Great news - thanks for being the town crier and telling us this breaking news.

This meeting is to discuss the treatments for hepatitis C that Gilead has submitted to the FDA for approval in April of this year. Gilead filed the NDA (New Drug Application) for sofosbuvir on April 8, 2013.

Just thought I'd share this bit of terrific news with all of you. The FDA has approved inhaled insulin and I can give you a first hand account of how it works as my daughter was in an inhaled insulin study at our local Children's Hospital four years ago. The device is manufactured by Pfizer. I checked their website, but couldn't find any info on the device (?). I would encourage you to ask your endocrinologist when it is going to be available to the public.

Is this the December 16 announcement Or something new?

Vertex has begun the application process for approval with the fda. The process should be completed by the end of this year with approval coming shortly after that. The results are promising and I believe the fda is going to put it on the fast track for approval. My doctor told me 6 months ago it will be probably be ready by the end of 2010. Like pcds says though, there is no way to know for sure. It may be sometime in 2011 before it is available. Hang in there!

Fda approval for sitagliptin with insulin

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