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zheng791 ☆ US, 2013-08-03 23:45 (4707 d 08:36 ago) Posting: # 11187 Views: 7,076 |
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Hi All, I am compiling the ANDA dossier and found the BE was conducted by using generic 75 mg vs Brand 75 mg. The RLD is 300 mg. When I checked the guidance, they always said RLD. Is this BE acceptable? Thank you very much |
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ElMaestro ★★★ Denmark, 2013-08-04 00:17 (4707 d 08:04 ago) @ zheng791 Posting: # 11188 Views: 6,418 |
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Hi zheng791, ❝ I am compiling the ANDA dossier and found the BE was conducted by using generic 75 mg vs Brand 75 mg. The RLD is 300 mg. When I checked the guidance, they always said RLD. Is this BE acceptable? I don't think showing BE against a non-RLD will work. Check out §314.127 here. - for example clause (4)(i). Note that it might be a mistake if one strength of the market leader is not assigned RLD status but chances are slim. Options: Submit and hope for the best, or petition FDA to make them designate RLD status to your comparator strength. — Pass or fail! ElMaestro |
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jag009 ★★★ NJ, 2013-08-04 00:51 (4707 d 07:30 ago) @ ElMaestro Posting: # 11189 Views: 6,312 |
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Hi, ❝ Options: Submit and hope for the best, or petition FDA to make them designate RLD status to your comparator strength. (FDA) Correct and they will not accept it unless you petition for approving the lower strength as a RLD. John |
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zheng791 ☆ US, 2013-08-04 01:55 (4707 d 06:26 ago) @ jag009 Posting: # 11193 Views: 6,342 |
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jag009 ★★★ NJ, 2013-08-04 22:20 (4706 d 10:01 ago) @ zheng791 Posting: # 11194 Views: 6,356 |
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Hi, ❝ I do see on approved ANDA list, some companies only have 75 mg strength. Does it make any sense? I don't understand your question. You mean 75mg exists as an RLD and the 300mg also exists as an RLD? Like i said, if you want to use 75mg as RLD and it currently does not exist as RLD on the orange book, write a petition with reasons and send to FDA. John |
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luvblooms ★★ India, 2013-08-05 07:57 (4706 d 00:24 ago) (edited on 2013-08-05 08:21) @ jag009 Posting: # 11195 Views: 6,360 |
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Dear John Done that (submitted an ANDA with a BE on non RLD lower strength) for a highly variable statin and also got approval (along with bio-waiver for all the proportional lower strengths). Never got a query from FDA asking about why RLD has not been dosed. It could be one of its kind case but such things happen!!!  — ~A happy Soul~ |
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ElMaestro ★★★ Denmark, 2013-08-05 12:44 (4705 d 19:38 ago) @ luvblooms Posting: # 11198 Views: 6,329 |
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Hi lb, ❝ Done that (submitted an ANDA with a BE on non RLD lower strength) for a highly variable statin and also got approval (along with bio-waiver for all the proportional lower strengths). Sounds very fishy to me. I think it would render the FDA liable if the originator sues the FDA as a means of brand protection. Was this one of the cases where an originator RLD was not available, perhaps? — Pass or fail! ElMaestro |
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luvblooms ★★ India, 2013-08-05 15:46 (4705 d 16:35 ago) @ ElMaestro Posting: # 11199 Views: 6,370 |
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Dear ElMaestro ❝ Sounds very fishy to me. Can you please explain what exactly do you mean by fishy? ❝ I think it would render the FDA liable if the originator sues the FDA as a means of brand protection. Was this one of the cases where an originator RLD was not available, perhaps? The drug product what we used, is available in four strengths, x, 2x, 4X and 8x where 8X was RLD but we have used 4x for our study purpose (done fasting and fed study on the same against 4X reference product) and submitted the dossier/ANDA for x, 2x and 4x (based on proportionality and matching dissolution profile) and not claimed for 8x, the RLD. This is what we used and got through. To each his own, I assume — ~A happy Soul~ |
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ElMaestro ★★★ Denmark, 2013-08-05 15:59 (4705 d 16:22 ago) @ luvblooms Posting: # 11200 Views: 6,273 |
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Hello lb, ❝ Can you please explain what exactly do you mean by fishy? Strange/unexpected/odd/outlier-ish/of dubious nature/involving some unexpected fine print etc. ❝ To each his own, I assume No, let's not go there. — Pass or fail! ElMaestro |
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luvblooms ★★ India, 2013-08-05 16:31 (4705 d 15:50 ago) @ ElMaestro Posting: # 11201 Views: 6,265 |
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Dear ElMaestro ❝ Strange/unexpected/odd/outlier-ish/of dubious nature/involving some unexpected fine print etc. That is the reason i said To each his own ❝ No, let's not go there. It is ok if you dont want to discuss it further But there are examples available on Drugs@FDA all you need to do is search. For e.g. Nifedipine.Period!! — ~A happy Soul~ |
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ElMaestro ★★★ Denmark, 2013-08-05 17:04 (4705 d 15:17 ago) @ luvblooms Posting: # 11203 Views: 6,230 |
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hi lb, ❝ It is ok if you dont want to discuss it further ❝ ❝ Period!! Terribly sorry if I upset you. No intention to do that from my side. Respectfully, for reasons we do not need to discuss on this forum I am not a fan of the expression. It is interesting to hear about your approval and I would certainly like to learn more. Did the FDA never question the RLD issue? I thought the FDA had to reject 505(j) submissions where a non-RLD was used as pivotal comparator. Was there any petition process or did you signal the intention to petition FDA? Does any law, guideline or guidance make exceptions to the RLD use? Was there any particular aspect of your product or your dossier which caused the FDA to approve it in spite of the use of a non-RLD? — Pass or fail! ElMaestro |
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jag009 ★★★ NJ, 2013-08-05 18:02 (4705 d 14:19 ago) @ luvblooms Posting: # 11207 Views: 6,283 |
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Hi Luvbloom, ❝ It is ok if you dont want to discuss it further ❝ ❝ Period!! Why do you need to "PERIOD!!"? You were mad or something? Apparently, you hit a nerve on me with Nifedipine. See Nifedipine ER Draft Guidance. FDA wants 3 studies, a fasting study (can't be a HVD design) on 90 mg the RLD, a fed study on the 90 mg, and 1 fasting on 60 mg. So 90 mg can be HVD and 60 mg is not HVD? I don't get it.. Guidance Dated 9/12 Ok, I assume I can run HVD designs on both 60 and 90... John |
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Helmut ★★★   Vienna, Austria, 2013-08-05 18:37 (4705 d 13:44 ago) @ jag009 Posting: # 11209 Views: 6,259 |
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Hi John, ❝ […] FDA wants 3 studies, 2 of which are RSABE studies on 90 mg the RLD, and 1 fasting on 60 mg (? It's not RLD, huh?) So 90 mg is HVD and 60 mg is not HVD? 60 mg not RLD is strange indeed. I guess you misinterpreted the guidance. For the 60 mg fasting study I read: “Additional Comments: Please see comments [sic] above.“ Since they cannot mean the comment on fed studies, this leaves only the 90 mg fasting study with a reference to the progesterone guidance (=HVD…). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2013-08-05 18:45 (4705 d 13:36 ago) @ Helmut Posting: # 11210 Views: 6,713 |
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Hi Helmut, ❝ 60 mg not RLD is strange indeed. I guess you misinterpreted the guidance. For the 60 mg fasting study I read:...Since they cannot mean the comment on fed studies, this leaves only the 90 mg fasting study with a reference to the progesterone guidance (=HVD…). Sorry I misread something. This particular guidance is for Adalat CC which has 60 mg and 90 mg as RLDs. Procardia XL has RLD as 90 mg only. But I don't get why require 90 mg and 60 mg studies?, particular only 1 study for 60 mg... Oh well... John |
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luvblooms ★★ India, 2013-08-05 19:30 (4705 d 12:51 ago) @ jag009 Posting: # 11212 Views: 6,216 |
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Hi John ❝ Why do you need to "PERIOD!!"? You were mador somehing? No, I was not angry but it was not leading anywhere so wanted to stop it. By the way did you checked Watson's approval. They did studies on 60 and 30 mg istead of 90 and 60 mg and they have not claimed for 90 mg. There are several other examples as well. — ~A happy Soul~ |
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jag009 ★★★ NJ, 2013-08-05 19:52 (4705 d 12:30 ago) @ luvblooms Posting: # 11213 Views: 6,279 |
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Hi Luvbloom, ❝ By the way did you checked Watson's approval. They did studies on 60 and 30 mg istead of 90 and 60 mg and they have not claimed for 90 mg. Going there now... Did you look at my post "strange"? What do you think? But was Waton's nifedipine for Adalat CC or Procardia XL? If for adalat CC, since the 60 mg is the RLD listed then I guess they can run studies on 60 and 30mg only to file. But that particular guidance is really strange, asking for fasting (can be HVD design) on 90mg, 2x2x2 on fed on 90mg and 2x2x2 fast on 60mg. I don't get the logic.. John |
Ing. Helmut Schütz