Gregory Glass | Site-Wide Activity https://fdapetitions.com/activity/ Activity feed for the entire site. Thu, 19 Mar 2026 12:59:42 +0000 https://buddypress.org/?v= en-US 30 hourly 2 4264b93978ed69c282793f8ce313c1a2 gregoryglass started the topic Fludarabine Phosphate Injection in the forum Safety Petitions https://fdapetitions.com/forums/topic/fludarabine-phosphate-injection/ Thu, 14 Dec 2023 15:40:07 +0000 Product: Fludarabine Phosphate Injection
Company: Sandoz
Petition Filer: Hisun
Petition Number(s): 2023P-5450
Date of Petition: December 13, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Fludarabine Phosphate Injection (NDA 022137) was removed from the market for…Read more

]]> 5f241573ae212a6d0b4d49003d62ea98 gregoryglass started the topic Atropine Sulfate Injection in the forum Suitability Petitions https://fdapetitions.com/forums/topic/atropine-sulfate-injection-2/ Thu, 14 Dec 2023 13:41:01 +0000 Product: Atropine Sulfate Injection
Company: Fresenius Kabi
Petition Filer: Biotech Research Group
Petition Number(s): 2023P-5409
Date of First Petition:
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a 4.0 mg/mL injection of atropine sulfate. It uses the Fresenius Kabi NDA…Read more

]]> 567277290454ae1779e9cf337a5e1750 gregoryglass started the topic Zoryve®(roflumislast) Cream in the forum Product Petitions https://fdapetitions.com/forums/topic/zoryveroflumislast-cream/ Fri, 08 Dec 2023 22:08:12 +0000 Product: Zoryve®(roflumislast) Cream
Company: Acutis
Petition Filer: Acutis
Petition Number(s): 2023P-5364
Date of Petition: December 6, 2023
Responding Petitions:

Issue and Implication: Whether standard bioequivalence test is sufficient to ensure sameness.

Action Requested by Petitioner: Petitioner is asking FDA to approve…Read more

]]> 6c328de46dbf11e0cca6d63ddf271568 gregoryglass started the topic Xipere®(triamcinolone) Injection in the forum Product Petitions https://fdapetitions.com/forums/topic/xiperetriamcinolone-injection/ Fri, 08 Dec 2023 21:51:52 +0000 Product: Xipere®(triamcinolone) Injection
Company: Bausch Lomb
Petition Filer: Bausch Lomb
Petition Number(s): 2023P-5343
Date of Petition: December 5, 2023
Responding Petitions:

Issue and Implication: Whether an ANDA must have the same injection device to be approved.

Action Requested by Petitioner: The Petitioner is asking…Read more

]]> a09eb816c6a65364206064673a55e82a gregoryglass started the topic Halaven®(eribulin) Injection in the forum Suitability Petitions https://fdapetitions.com/forums/topic/halaveneribulin-injection/ Wed, 29 Nov 2023 16:24:59 +0000 Product: Halaven®(eribulin) Injection
Company: Eisai
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2023P-5135
Date of First Petition: November 20, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a 2mg/4mL and 2.5mg/5mL vials of Halaven®(eribulin) Injection. U…Read more

]]> dfb9b7506d010008bc3d9f814c629c11 gregoryglass started the topic Vistaril®(hydroxyzine) Oral Solution in the forum Safety Petitions https://fdapetitions.com/forums/topic/vistarilhydroxyzine-oral-solution/ Wed, 29 Nov 2023 15:47:48 +0000 Product: Vistaril®(hydroxyzine) Oral Solution
Company: Pfizer
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2023P-5095
Date of Petition: November 17, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Vistaril®(hydroxyzine) Oral Solution 25mg/5mL (NDA 0…Read more

]]> b1fb5c20196460202a531e1f806d38cc gregoryglass started the topic Filsuvez® in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/filsuvez/ Wed, 08 Nov 2023 12:49:28 +0000 Product: Filsuvez®
Company: Amryt Pharma
Petition Filer: Lassman Law and Policy
Petition Number(s): 2023P-4918
Date of Petition: November 6, 2023
Responding Petitions:

Issue and Implication: Whether FDA can approve a product that does not demonstrate efficacy.

Action Requested by Petitioner: Petitioner is asking FDA to deny…Read more

]]> 900d553589bfb10580df3111a2650c19 gregoryglass started the topic Vigabatrin Oral Solution in the forum Product Petitions https://fdapetitions.com/forums/topic/vigabatrin-oral-solution/ Wed, 08 Nov 2023 12:35:58 +0000 Product: Vigabatrin Oral Solution
Company: Various
Petition Filer: Sidley Austin, a law firm
Petition Number(s): 2023P-4896
Date of Petition: November 6, 2023
Responding Petitions:

Issue and Implication: Whether FDA can grant a product Orphan Drug Exclusivity status when prior products have been designated as such.

Action…Read more

]]> 1f1064c2a005e8862f02a1fdf6823d16 gregoryglass started the topic Lodin®(etodolac) Tablets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/lodinetodolac-tablets/ Sat, 04 Nov 2023 19:44:10 +0000 Product: Lodin®(etodolac) Tablets
Company: Wyeth
Petition Filer: Pharmobedient
Petition Number(s): 2023P-4877
Date of First Petition: November 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a 200 mg and 250 mg tablet of Lodin®(etodolac). It uses RLD (NDA #N018922) as t…Read more

]]> a73911d72825db566f838bee4c3fc3e0 gregoryglass started the topic Imitrex®(sumatriptan) Oral Solution in the forum Suitability Petitions https://fdapetitions.com/forums/topic/imitrexsumatriptan-oral-solution/ Tue, 31 Oct 2023 13:48:44 +0000 Product: Imitrex®(sumatriptan) Oral Solution
Company: GlaxosmithKline
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2023P-4784
Date of First Petition: October 30, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for am oral solution form of Imitrex®(sumatriptan) O…Read more

]]> c737db4ac4d21045e7623b93d335edc0 gregoryglass started the topic Zipsor®(diclofenac) Capsules and OS in the forum Suitability Petitions https://fdapetitions.com/forums/topic/zipsordiclofenac-capsules/ Tue, 24 Oct 2023 15:53:11 +0000 Product: Zipsor®(diclofenac) Capsules
Company: Assertio
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2023P-4659
Date of First Petition: October 23, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a Zipsor®(diclofenac) Capsules 12.5mg. The RLD is the 25mg s…Read more

]]> 78b43e5a1d56b71a3ee5db6590f92e56 gregoryglass started the topic Neurontin®(gabapentin) Capsules and Tablets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/neurontingabapentin-capsules/ Tue, 24 Oct 2023 15:44:03 +0000 Product: Neurontin®(gabapentin) Capsules
Company: Viatris
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2023P-4568
Date of First Petition: October 23, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a Neurontin®(gabapentin) Capsules in a variety of new dosage s…Read more

]]> 98b8005a9de70c1b8150726d4c9b4f2b gregoryglass started the topic Isuprel®(isptroterenol) Injection in the forum Safety Petitions https://fdapetitions.com/forums/topic/isuprelisptroterenol-injection/ Sat, 21 Oct 2023 14:41:18 +0000 Product: Isuprel®(isptroterenol) Injection
Company: Bausch Health
Petition Filer: 2023P-4636
Petition Number(s): E. Rust Consulting
Date of Petition: October 20, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Isuprel®(isptroterenol) Injection (NDA 010515) was r…Read more

]]> 053422da5d29213ba4d3f250caee76a7 gregoryglass started the topic Sitagliptin Tablets in the forum Product Petitions https://fdapetitions.com/forums/topic/sitagliptin-tablets/ Sat, 21 Oct 2023 14:31:46 +0000 Product: Sitagliptin Tablets
Company: Merck
Petition Filer: Zydus
Petition Number(s): 2023P-4616
Date of Petition: October 20, 2023
Responding Petitions:

Issue and Implication: Whether FDA should retract temporary guidance.

Action Requested by Petitioner: Petitioner asks FDA to remove all sitagliptin products that contain more…Read more

]]> c6c23ee88ce5b1ab2cee7512ec224a8a gregoryglass started the topic Trandate®(labetalol) Injection in the forum Suitability Petitions Archives https://fdapetitions.com/forums/topic/trandatelabetalol-injection/ Thu, 19 Oct 2023 13:53:20 +0000 Product: Trandate®(labetalol) Injection
Company: Sevela Ireland
Petition Filer: None S Consulting
Petition Number(s): 2023P-4552
Date of First Petition: October 17, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a Trandate®(labetalol) Injection 20mg/4 mL (5mg/mL) Prefilled S…Read more

]]> 2200c9994d834fc82afef2a7aa80f9ba gregoryglass started the topic Atropine Sulfate Ophthalmic Ointment in the forum Suitability Petitions https://fdapetitions.com/forums/topic/atropine-sulfate-ophthalmic-ointment/ Thu, 19 Oct 2023 12:22:07 +0000 Product: Atropine Sulfate Ophthalmic Ointment
Company: Akorn
Petition Filer: Pharmobedient
Petition Number(s): 2023P-4550
Date of First Petition: October 17, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a Atropine Sulfate Ophthalmic Ointment 1% using the ANDA (NDA 206289) as…Read more

]]> 373b26251a3420fdcb0f0e752c68f202 gregoryglass started the topic Mephyton®(phytonadione) Tablets in the forum Safety Petitions Archives https://fdapetitions.com/forums/topic/mephytonphytonadione-tablets/ Thu, 19 Oct 2023 12:08:26 +0000 Product: Mephyton®(phytonadione) Tablets
Company: Bausch Health
Petition Filer: Lachman Consultants
Petition Number(s): 2023P-4596
Date of Petition: October 18, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Mephyton®(phytonadione) Tablets (NDA 010104) was r…Read more

]]> c15bddf167933e5575ab95624f7d64a0 gregoryglass started the topic Kemstro®(baclofen) Orally Disintegrating Tablets in the forum Safety Petitions https://fdapetitions.com/forums/topic/kemstrobaclofen-orally-disintegrating-tablets/ Thu, 19 Oct 2023 12:03:55 +0000 Product: Kemstro®(baclofen) Orally Disintegrating Tablets
Company: UCB
Petition Filer: Pharmobedient
Petition Number(s): 2023P-4587
Date of Petition: October 18, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Kemstro®(baclofen) Orally Disintegrating Tablets (NDA 0…Read more

]]> 31b2f94e933e2f8fde1c9a2eee4ee3ef gregoryglass started the topic Ycanth®(cantharidin) Topical Solution in the forum Product Petitions https://fdapetitions.com/forums/topic/ycanthcantharidin-topical-solution/ Sat, 14 Oct 2023 13:15:49 +0000 Product: Ycanth®(cantharidin) Topical Solution
Company: Verrica Pharmaceuticals
Petition Filer: Verrica Pharmaceuticals
Petition Number(s): 2023P-4510
Date of Petition: October 12, 2023
Responding Petitions:

Issue and Implication: Whether FDA should remove Active Pharmaceutical Ingredients from the bulk and compounding list when…Read more

]]> 927f596b47ad4632695b85552803a645 gregoryglass started the topic Zinc Sulfate Injection in the forum Suitability Petitions https://fdapetitions.com/forums/topic/zinc-sulfate-injection/ Sat, 14 Oct 2023 13:02:48 +0000 Product: Zinc Sulfate Injection
Company: American Regent
Petition Filer: Gland Pharma
Petition Number(s): 2023P-4463
Date of First Petition:
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for two additional dosage strengths (or presentations) of Zinc Sulfate Injection. It uses the…Read more

]]> 69a3eea612034ae3e241721f7d028b4b gregoryglass started the topic Selenious Acid Injection in the forum Suitability Petitions https://fdapetitions.com/forums/topic/selenious-acid-injection/ Thu, 12 Oct 2023 14:34:14 +0000 Product: Selenious Acid Injection
Company: American Regent
Petition Filer: Pharmobedient
Petition Number(s): 2023P-4465
Date of First Petition: October 11, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a selenious acid injection using the RLD (N209379). It is not clear as…Read more

]]> 0e0a85b23f663a60a86222c0a6c0b56b gregoryglass started the topic Glucotrol®(glipizide) Tablets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/glucotrolglipizide-tablets-2/ Thu, 12 Oct 2023 13:55:38 +0000 Product: Glucotrol®(glipizide) Tablets
Company: Pfizer
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2023P-4443
Date of First Petition: October 11, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a scored 15mg tablet of glipizide. Using Glucotrol®(glipizide) T…Read more

]]> a5fd466154fe71d81f91731c65ef942c gregoryglass started the topic Desyrel®(trazodone) Tablets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/desyreltrazodone-tablets/ Wed, 11 Oct 2023 11:26:59 +0000 Product: Desyrel®(trazodone) Tablets
Company: Pragma
Petition Filer: Drug Device Consulting
Petition Number(s): 2023P-4394
Date of First Petition: October 10, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a Desyrel®(trazodone) Tablets 25 and 75mg. It uses the D…Read more

]]> 01555bc3e15a8161964bab1b921cb9f9 gregoryglass started the topic Bromday®(bromfenac) Solution in the forum Suitability Petitions https://fdapetitions.com/forums/topic/bromdaybromfenac-solution/ Fri, 06 Oct 2023 15:14:50 +0000 Product: Bromday®(bromfenac) Solution
Company: Bausch and Lomb and Alembic
Petition Filer: Pharmobedient
Petition Number(s): 2023P-4359
Date of First Petition: October 5, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a 0.08% strength of bromfenac solution/drops. It uses…Read more

]]> bf7bb403e0ad404e6f3f2ebbc06c2d9a gregoryglass started the topic Sterile Water for Irrigation in the forum Suitability Petitions Archives https://fdapetitions.com/forums/topic/sterile-water-for-irrigation/ Wed, 04 Oct 2023 16:18:17 +0000 Product: Sterile Water for Irrigation
Company: B. Braun Medical
Petition Filer: Fresenius Kabi
Petition Number(s): 2023P-4331
Date of First Petition: October 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for Sterile Water for Irrigation in 250mL and 1500mL fill sizes. It…Read more

]]> 3aa7785cab2af356c5bdd50677c5e1fc gregoryglass started the topic Dexchlorpheniramine Sachets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/dexchlorpheniramine-sachets/ Wed, 04 Oct 2023 16:09:57 +0000 Product: Dexchlorpheniramine Sachets
Company: PAI Holdings and Capellon
Petition Filer: Pharmobedient
Petition Number(s): 2023P-4327
Date of First Petition: October 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a Dexchlorpheniramine Powder for Solution, 2mg/Sachet. It…Read more

]]> 4e1d64bbbcd917bebda7c1d701a3fed1 gregoryglass started the topic Sodium Chloride Irrigation in the forum Suitability Petitions Archives https://fdapetitions.com/forums/topic/sodium-chloride-irrigation/ Wed, 04 Oct 2023 16:00:09 +0000 Product: Sodium Chloride Irrigation
Company: B. Braun Medical
Petition Filer: Fresenius Kabi
Petition Number(s): 2023P-4324
Date of First Petition: October 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a Sodium Chloride Irrigation 0.9% 250mL and 1500mL fill sizes in…Read more

]]> 03bf6bcd651aff6e5c3136e8285c4927 gregoryglass started the topic Inderal®(propranolol) Orally Disintegrating Tablets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/inderalpropranolol-orally-disintegrating-tablets/ Wed, 04 Oct 2023 13:45:53 +0000 Product: Inderal®(propranolol) Orally Disintegrating Tablets
Company: Wyeth
Petition Filer: Lachman Consultants
Petition Number(s): 2023P-4320
Date of First Petition: October 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for Inderal®(propranolol) Orally Disintegrating T…Read more

]]> 17abc71542ab42895c18316ccdca1214 gregoryglass started the topic Lymphazurin®(isosulfan blue) Injection in the forum Suitability Petitions https://fdapetitions.com/forums/topic/lymphazurinisosulfan-blue-injection/ Wed, 04 Oct 2023 13:41:36 +0000 Product: Lymphazurin®(isosulfan blue) Injection
Company: Covidien
Petition Filer: Lachman Consultants
Petition Number(s): 2023P-4297
Date of First Petition: October 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a 1%, 1mL prefilled syringe of Lymphazurin®(isosulfan b…Read more

]]> f21961878b5741b447907b0253a45736 gregoryglass started the topic Tavist®(clemastine) Sachet and Orally Disintegrating Tablets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/tavistclemastine-sachet/ Wed, 04 Oct 2023 13:31:55 +0000 Product: Tavist®(clemastine) Sachet
Company: Novartis
Petition Filer: Pharmobedient
Petition Number(s): 2023P-4292
Date of First Petition: October 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a 1mg and 2mg sachet form of Tavist®(clemastine) Powder (NDA 018675) which r…Read more

]]> 5d7fc73a012e14db394dd29f5009eea3 gregoryglass started the topic Daypro®(oxaprozin) Tablets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/dayprooxaprozin-tablets/ Wed, 04 Oct 2023 13:26:29 +0000 Product: Daypro®(oxaprozin) Tablets
Company: Pfizer
Petition Filer: Pharmobedient
Petition Number(s): 2023P-4290
Date of First Petition: October 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a 300mg and 1200mg strength of Daypro®(oxaprozin) Tablets (NDA 018841). Using t…Read more

]]> b83dd8ed1db7eaebfdce1d5f540691e8 gregoryglass started the topic Paxil®(paroxetine) Orally Disintegrating Tablets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/paxilparoxetine-orally-disintegrating-tablets/ Wed, 04 Oct 2023 13:20:35 +0000 Product: Paxil®(paroxetine) Orally Disintegrating Tablets
Company: Apotex
Petition Filer: Lachman Consultants
Petition Number(s): 2023P-4289
Date of First Petition: October 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a orally disintegrating form of…Read more

]]> 7c898bf025aa0706d4d7eea8fcea39a8 gregoryglass started the topic Flexeril®(cyclobenzaprine) Orally Disintegrating Tablets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/flexerilcyclobenzaprine-orally-disintegrating-tablets/ Wed, 04 Oct 2023 12:56:10 +0000 Product: Flexeril®(cyclobenzaprine) Orally Disintegrating Tablets
Company: Janssen
Petition Filer: Newcastle Bioscience
Petition Number(s): 2023P-4284
Date of First Petition: October 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a 5 mg and 10 mg orally disintegrating…Read more

]]> baf1e4df29a57e47ae9a24f42bfba9ae gregoryglass started the topic Clistin®(carbinoxamine) Orally Disintegrating Tablets and Powder in the forum Suitability Petitions https://fdapetitions.com/forums/topic/clistincarbinoxamine-orally-disintegrating-tablets/ Wed, 04 Oct 2023 12:50:55 +0000 Product: Clistin®(carbinoxamine) Orally Disintegrating Tablets
Company: Ortho McNeil and
Petition Filer: Pharmobedient
Petition Number(s): 2023P-4283
Date of First Petition: October 3, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a 4mg ODT form of…Read more

]]> 8b492b26d3efd8b954bede0f3691491d gregoryglass started the topic Qmiiz ODT®(meloxicam) Orally Disintegrating Tablets in the forum Safety Petitions https://fdapetitions.com/forums/topic/qmiiz-odtmeloxicam-orally-disintegrating-tablets/ Wed, 04 Oct 2023 12:38:44 +0000 Product: Qmiiz ODT®(meloxicam) Orally Disintegrating Tablets
Company: Tersera
Petition Filer: Pharmobedient
Petition Number(s): 2023P-4279
Date of Petition: October 3, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Qmiiz ODT®(meloxicam) Orally Disintegrating T…Read more

]]> d2007700eb70fdbb959afa0776febaaa gregoryglass started the topic Dolobid®(diflunisal) Orally Disintegrating Tablets in the forum Suitability Petitions https://fdapetitions.com/forums/topic/dolobiddiflunisal-odt/ Tue, 03 Oct 2023 16:49:17 +0000 Product: Dolobid®(diflunisal) Orally Disintegrating Tablets
Company: Merck, Teva
Petition Filer: Pharmobedient, a consulting firm
Petition Number(s): 2023P-4280
Date of First Petition: October 2, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for an orally disintegrating tablet…Read more

]]> 7a6102f0e1b168e848db2f5280f30d33 gregoryglass started the topic Buprenex®(buprenorphine) Injection in the forum Safety Petitions Archives https://fdapetitions.com/forums/topic/buprenexbuprenorphine-injection/ Fri, 29 Sep 2023 11:28:54 +0000 Product: Buprenex®(buprenorphine) Injection
Company: Indivior
Petition Filer: Odin Pharmaceuticals
Petition Number(s): 2023P-4223
Date of Petition: September 28, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Buprenex®(buprenorphine) Injection (NDA 018401) was r…Read more

]]> cdf36ffc70562cbda395303ba0134294 gregoryglass started the topic Nucynta®(tapentadol) Oral Solution in the forum Safety Petitions https://fdapetitions.com/forums/topic/nucyntatapentadol-oral-solution/ Tue, 26 Sep 2023 11:00:34 +0000 Product: Nucynta®(tapentadol) Oral Solution
Company: Collegium
Petition Filer: Novitium
Petition Number(s): 2023P-4065
Date of Petition: September 20, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Nucynta®(tapentadol) Oral Solution (NDA 203794) was removed from t…Read more

]]> 3a5ddc4aacfbea39831c8e4157493fc4 gregoryglass started the topic Zofran®(ondasentron) Orally Disintegrating Tablets in the forum Safety Petitions Archives https://fdapetitions.com/forums/topic/zofranondasentron-orally-disintegrating-tablets/ Tue, 29 Aug 2023 14:05:43 +0000 Product: Zofran®(ondasentron) Orally Disintegrating Tablets
Company: Sandoz
Petition Filer: Sun Pharmaceutical Industries
Petition Number(s): 2023P-3682
Date of Petition: August 28, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Zofran®(ondasentron) Orally D…Read more

]]> d425f7813d29c450a9fde2a3732e906a gregoryglass started the topic Synapse Labs Pvt Products in the forum Product Petitions https://fdapetitions.com/forums/topic/synapse-labs-pvt-products/ Sat, 26 Aug 2023 20:03:44 +0000 Product: Synapse Labs Pvt Products
Company: Synapse Labs
Petition Filer: The Flag
Petition Number(s): 2023P-3634
Date of Petition: August 25, 2023
Responding Petitions:

Issue and Implication: Whether a foreign agency’s audit of a manufacturer determine TE codes in the US.

Action Requested by Petitioner: The Petitioner is asking…Read more

]]> 93dcbbc699d98a2abb61596707610816 gregoryglass started the topic Ozobax®(baclofen) Oral Solution in the forum Product Petitions https://fdapetitions.com/forums/topic/ozobaxbaclofen-oral-solution/ Tue, 22 Aug 2023 13:21:21 +0000 Product: Ozobax®(baclofen) Oral Solution
Company: Metacel
Petition Filer: Metacel
Petition Number(s): 2023P-3574
Date of Petition: August 21, 2023
Responding Petitions:

Issue and Implication: Whether an ANDA filer must conduct the same safety studies FDA required of the Petitioner/Drug Sponsor.

Action Requested by Petitioner: …Read more

]]> 9761c286ea3d80f42834be70c1a2daab gregoryglass started the topic Sezaby®(phenobarbital sodium) Injection in the forum Product Petitions https://fdapetitions.com/forums/topic/sezabyphenobarbital-sodium-injection/ Wed, 26 Jul 2023 16:17:52 +0000 Product: Sezaby®(phenobarbital sodium) Injection
Company: Sun Pharma
Petition Filer: Sun Pharma
Petition Number(s): 2023P-3078
Date of Petition: July 25, 2023
Responding Petitions:

Issue and Implication: Whether FDA can remove an unapproved product that is marketed due to its excipients.

Action Requested by Petitioner: The…Read more

]]> 83f3cd9d31199667c28fb5a2115b1867 gregoryglass started the topic Romidepsin Injection in the forum Safety Petitions https://fdapetitions.com/forums/topic/romidepsin-injection/ Thu, 13 Jul 2023 11:42:48 +0000 Product: Romidepsin Injection
Company: Teva
Petition Filer: E. Rust Consulting
Petition Number(s): 2023P-2874
Date of Petition: July 12, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Romidepsin Injection 10mg/2mL and 27.5mg/5.5mL (5mg/mL) (NDA 205574) was removed…Read more

]]> 50855741530f0c3d30d67c58e0ad82c7 gregoryglass started the topic Animal-derived Ingredients in the forum Issue Petitions https://fdapetitions.com/forums/topic/animal-derived-ingredients/ Thu, 13 Jul 2023 11:35:54 +0000 Issue: Animal-derived Ingredients
Petition Filer: VeganMed
Petition Number(s): 2023P-2852
Date of Petition: July 11,2023
Responding Petitions:

Issue and Implication: Whether drugs are mis-labeled or adulterated if they contain ingredients derived from animals.

Action Requested by Petitioner: The Petitioner is asking that FDA…Read more

]]> 5e18f7faa74ae1e36d9ea240c2d36202 gregoryglass started the topic Ultram®(tramadol) Tablets in the forum Safety Petitions Archives https://fdapetitions.com/forums/topic/ultramtramadol-tablets/ Sun, 02 Jul 2023 11:55:37 +0000 Product: Ultram®(tramadol) Tablets
Company: Janssen
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2023P-2656
Date of Petition: June 29, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Ultram®(tramadol) Tablets 50mg (NDA 020281) was removed from the m…Read more

]]> 885a20f9d11ebab074d5e44956d66bed gregoryglass started the topic Foradil®(formoterol) Inhalation Powder in the forum Safety Petitions Archives https://fdapetitions.com/forums/topic/foradilformoterol-inhalation-powder/ Fri, 23 Jun 2023 18:49:36 +0000 Product: Foradil®(formoterol) Inhalation Powder
Company: Novartis
Petition Filer: K&L Gates, a law firm
Petition Number(s): 2023P-2536
Date of Petition: June 21, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Foradil®(formoterol) Inhalation Powder (NDA 020831) was r…Read more

]]> 849bda27e35c67f7e40ddc64c1c80f2d gregoryglass started the topic Neffy®(epinephrine) Intranasal in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/neffyepinephrine-intranasal/ Tue, 13 Jun 2023 17:52:08 +0000 Product: Neffy®(epinephrine) Intranasal
Company: ARS Pharmaceuticals
Petition Filer: Viatris
Petition Number(s): 2023P-2392
Date of Petition: June 12, 2023
Responding Petitions:

Issue and Implication: Whether FDA can approve a 505(b)(2) NDA that uses a different route of administration than the reference list drugs.

Action…Read more

]]> 0565a072da03ce3c664166b3e7931cda gregoryglass started the topic K-Tab®(potassium) Extended-release Tablets in the forum Safety Petitions Archives https://fdapetitions.com/forums/topic/k-tabpotassium-extended-release-tablets/ Sat, 10 Jun 2023 19:18:15 +0000 Product: K-Tab®(potassium) Extended-release Tablets
Company: Abbvie
Petition Filer: Granules
Petition Number(s): 2023P-2339
Date of Petition: June 8, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether K-Tab®(potassium) Extended-release Tablets (NDA 018279) was removed f…Read more

]]> 837d32319f63c3e824fcb515d01eedd4 gregoryglass started the topic Mexitil®(mexiletine) Capsules in the forum Suitability Petitions https://fdapetitions.com/forums/topic/mexitilmexiletine-capsules/ Sat, 27 May 2023 10:34:14 +0000 Product: Mexitil®(mexiletine) Capsules
Company: Boehringer Ingelheim
Petition Filer: Rising Pharma
Petition Number(s): 2023P-2157
Date of First Petition: May 26, 2023
Responding Petitions: None

Action Requested of Petition: Petitioner would like to file an ANDA for a 300 mg strength of mexiletine capsules. Using…Read more

]]> 67db10f3d5b22812fbcb9dea5f594b09 gregoryglass started the topic Cogentin®(benztropine) Injection in the forum Safety Petitions Archives https://fdapetitions.com/forums/topic/cogentinbenztropine-injection/ Wed, 24 May 2023 12:37:25 +0000 Product: Cogentin®(benztropine) Injection
Company: Akorn
Petition Filer: Nexus
Petition Number(s): 2023P-2055
Date of Petition: May 222, 2023
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Cogentin®(benztropine) Injection (NDA 012015) was removed from the market for r…Read more

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