The ELTP King
9 hours ago
Capsules is spelled wrong.
I will contact Dianne.
***** NEW *****
Elite JUST added Vyvanse to their OFFICIAL website TODAY:
Lisdexamfetamine Dimesylate Capsults
10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg
Approved, not commercialized. Vyvanse® CNS Stimulant
https://elitepharma.com/products/
The ELTP King
9 hours ago
***** NEW *****
Elite JUST added Vyvanse to their OFFICIAL website TODAY:
Lisdexamfetamine Dimesylate Capsults
10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg
Approved, not commercialized. Vyvanse® CNS Stimulant
https://elitepharma.com/products/
sharkey1
12 hours ago
I think one reason for not changing the fiscal at this time is because it would create a bit of an illusion or shell game
, If changed now, the next fiscal would have to wait 90 days, and the first 3 months of next year would be reported later and would only be in the next fiscal ending in dec, 2025, so that included Vyvanse sales, Huge Vyvanse
sales, sure we will see them as a quarter sales bit not year end totals , would make it look like yearly of Elite
not aa big for the first filing next year,
I need help, lol
HGilS
15 hours ago
Nasrat: Elite has 3 additional product launches in the next few months. Hydrocodone with APAP, which is the generic for Norco, which is expected to launch in the next few weeks, I would say around the 1st week of December.
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.
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he most important launch is the one that is not approved yet. The central nervous system and the pending approval by FDA, we expect to hear from FDA on November 23rd. Yes. I know it's a Saturday, But that's what FDA said. We will give you an answer on November 23rd.
When approved, this ANDA becomes our number one priority to launch. We will issue a press release upon approval. I'll say a couple of thoughts about this because that's a very important product. The API supply, supplier had issues with the DMF. We are not allowed to see the DMF.
We only give, FDA authorization to, look at the EMF and approve it after the vendor lets us do that. So FDA does, once the FDA looked at it and noticed some problems, they updated us and so did our supplier. They said that they have some issues with us. Our application, to the best of my knowledge, and as per FDA, did not have any issues with it. So now, all observations by the API supplier have been addressed.
We have evaluated them and they look adequate, and we believe the FDA will find them adequate as well. If the FDA does, then approval come in next week. If it doesn't, there is nothing that I've seen that looks like it's major. It will be a minor amendment that we will work with FDA to to see how fast we can get into, the market. As of now, Doug and Kirkland are lining up for launch in end of December or early January.