Gregory Glass | gregoryglass | Activity https://fdapetitions.com/members/gregoryglass-d27/activity/ Activity feed for gregoryglass. Thu, 19 Mar 2026 12:59:42 +0000 https://buddypress.org/?v= en-US 30 hourly 2 bed00d3a5944dda77c77f1bf459ea860 gregoryglass started the topic Protonix®(pantoprazole) DR Oral Suspension in the forum Suitability Petitions https://fdapetitions.com/forums/topic/protonix-pantoprazole-dr-oral-suspension/ Mon, 25 Nov 2019 18:45:54 +0000 Product: Protonix®(pantoprazole) Delayed-release Oral Suspension
Company: Wyeth
Petition Filer: Foley Lardner, a law firm
Petition Number(s): 2019P-5535
Date of First Petition: November 22, 2019
Responding Petitions: None

Action Requested of Petition: The Petitioner is requesting the FDA to allow the manufacture of an oral…Read more

]]> 0e6ff4e3664981bd0c0d123f56fac411 gregoryglass started the topic Penicillamine Capsules in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/penicillamine-capsules/ Wed, 20 Nov 2019 18:55:54 +0000 Product: Penicillamine Capsules
Company: Apicore
Petition Filer: Apicore
Petition Number(s): 2019P-5463 and 2019P-5571
Date of Petition: November 20, 2019
Responding Petitions:

Issue and Implication: Whether current FDA standards are sufficient to ensure bioequivalence.

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

]]> 38bf6efe29bb09999f36dc4369c2b231 gregoryglass started the topic Polymyxin B Sulfate Injection in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/polymyxin-b-sulfate-injection/ Wed, 20 Nov 2019 18:41:55 +0000 Product: Polymyxin B Sulfate Injection
Company: Various, Xellia
Petition Filer: Hyman Phelps, a law firm
Petition Number(s): 2019P-5441
Date of Petition: November 19, 2019
Responding Petitions:

Issue and Implication: Whether FDA must designate a second Reference Standard.

Action Requested by Petitioner: Petitioner is requesting…Read more

]]> 2a441cd3daa965a606b68e9635cc598b gregoryglass started the topic Augmentin XR®(amoxicillin and clavulanate) Extended-release Tablets in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/augmentin-xr-amoxicillin-and-clavulanate-extended-release-tablets/ Thu, 07 Nov 2019 13:38:11 +0000 Product: Augmentin XR®(amoxicillin and clavulanate) Extended-release Tablets
Company: Neopharma
Petition Filer: Aurobindo
Petition Number(s): 2019P-5237
Date of Petition: November 6, 2019
Responding Petitions:

Issue and Implication: Whether FDA must designate a second Reference Standard.

Action Requested by Petitioner: Petitioner…Read more

]]> f996d3e8d968003c17b4eb257e2eb3b0 gregoryglass started the topic GlucaGen®(glucagon) Injection in the forum Product Petitions https://fdapetitions.com/forums/topic/glucagen-glucagon-injection/ Fri, 25 Oct 2019 14:28:57 +0000 Product: GlucaGen®(glucagon) Injection Company: Fresenius Kabi/Novo NordiskPetition Filer: Fresenius KabiPetition Number(s): 2019P-4962Date of Petition: October 24, 2019Responding Petitions: Issue and Implication: Whether a 505(b)(2) NDA product merits an “A” rating with a similar drug.Action Requested by Petitioner: The Petitioner is aski…Read more

]]> 5abf13d2724b36b48db9ab9d56c21c49 gregoryglass started the topic Diastat®(diazepam) Rectal Gel and Valtoco®(diazepam) Intranasal Solution in the forum Product Petitions Archives http://fdapetitions.com/forums/topic/diastat-diazepam-rectal-gel-and-valtoco-diazepam-intranasal-solution/ Fri, 18 Oct 2019 19:41:37 +0000 Product: Diastat®(diazepam) Rectal Gel and Valtoco®(diazepam) Intranasal Solution
Company: Bausch Health/Neurelis
Petition Filer: Aquestive
Petition Number(s): 2019P-4832 and 2019P-5121
Date of Petition: October 17, 2019 and November 4, 2019
Responding Petitions: Neurelis

Issue and Implication: Whether the Orphan Drug Act and c…Read more

]]> aff826de03fffb15b780da77a43701de gregoryglass started the topic Somatuline® Depot (lanreotide) Injection in the forum Product Petitions https://fdapetitions.com/forums/topic/somatuline-depot-lanreotide-injection/ Fri, 18 Oct 2019 19:23:45 +0000 Product: Somatuline® Depot (lanreotide) Injection
Company: Ipsen SA
Petition Filer: Ipsen SA
Petition Number(s): 2019P-4830
Date of Petition: October 17, 2019
Responding Petitions:

Issue and Implication: Whether current FDA regulations are sufficient to ensure bioequivalence.

Action Requested by Petitioner: The Petitioner is…Read more

]]> 950f6ee688414e89df0bf1eb3610cbd3 gregoryglass started the topic Jatenzo®(testosterone) Capsule and Testosterone-ester prodrugs in the forum Product Petitions https://fdapetitions.com/forums/topic/jatenzo-testosterone-capsule-and-testosterone-ester-prodrugs/ Fri, 11 Oct 2019 14:36:50 +0000 Product: Jatenzo®(testosterone) Capsule and Testosterone-ester prodrugs Company: Clarus TherapeuticsPetition Filer: Clarus TherapeuticsPetition Number(s): 2019P-4644Date of Petition: October 10, 2019Responding Petitions: Issue and Implication: Whether FDA must create and publish guidance for clinical study criteria for a class of…Read more

]]> 49dae6741f2f071b68b4902585404657 gregoryglass started the topic Makena®(hydroxyprogesterone) Injection in the forum Product Petitions https://fdapetitions.com/forums/topic/makena-hydroxyprogesterone-injection/ Wed, 09 Oct 2019 14:42:32 +0000 Product: Makena®(hydroxyprogesterone) Injection
Company: AMAG Pharma and various
Petition Filer: Public Citizen
Petition Number(s): 2019P-4683
Date of Petition: October 8, 2019
Responding Petitions: AMAG Pharma

Issue and Implication: Whether FDA approval is sufficient to ensure the safe use and efficacy of any product.

Action…Read more

]]> 6bf8482af3ff815e3c01d78558e13b9c gregoryglass started the topic Vesicare®(solifenacin) Orally Disintegrating Tablets in the forum Suitability Petitions Archives https://fdapetitions.com/forums/topic/vesicare-solifenacin-orally-disintegrating-tablets/ Tue, 08 Oct 2019 17:44:57 +0000 Product: Vesicare®(solifenacin) Orally Disintegrating Tablets
Company: Astellas
Petition Filer: Intas
Petition Number(s): 2019P-4645
Date of First Petition: October 14, 2014
Responding Petitions: None

Action Requested of Petition: Petitioner seeks permission to file an ANDA for an orally disintegrating tablets 5 and 10mg. The…Read more

]]> 9144689486add8c7bf826e58e160adfc gregoryglass started the topic Potassium Chloride in Dextrose and Sodium Chloride in the forum Safety Petitions Archives https://fdapetitions.com/forums/topic/potassium-chloride-in-dextrose-and-sodium-chloride/ Sat, 28 Sep 2019 10:55:08 +0000 Product: Potassium Chloride in Dextrose and Sodium Chloride
Company: ICU Medical Inc
Petition Filer: Fresenius Kabi
Petition Number(s): 2019P-4523
Date of Petition: September 27, 2019
Responding Petitions:

Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Potassium Chloride in Dextrose 5% and Sodium…Read more

]]> 6d9d64803e722ea2f4b78b79eecfe2bd gregoryglass started the topic Inderal®(propanolol) Tablets in the forum Product Petitions https://fdapetitions.com/forums/topic/inderal-propanolol-tablets/ Fri, 27 Sep 2019 14:14:14 +0000 Product: Inderal®(propanolol) Tablets Company: Wyeth/IMPAX labsPetition Filer: Foley Lardner, a law firmPetition Number(s): 2019P-4515Date of Petition: September 26, 2019Responding Petitions: Issue and Implication: Whether FDA must designate a second Reference Standard.Action Requested by Petitioner: Petitioner is requesting the FDA…Read more

]]> 8d8e436baf597649ddee1e2e85d722ee gregoryglass started the topic Cleocin T®(clindamycin) Topical Solution in the forum Product Petitions https://fdapetitions.com/forums/topic/cleocin-t-clindamycin-topical-solution/ Thu, 26 Sep 2019 23:19:03 +0000 Product: Cleocin T®(clindamycin) Topical Solution
Company: Pharmacia and Upjohn (Pfizer)
Petition Filer: Macleods
Petition Number(s): 2019P-4481
Date of Petition: September 26, 2019
Responding Petitions:

Issue and Implication: Whether FDA must designate a second Reference Standard.

Action Requested by Petitioner: The Petitioner…Read more

]]> 92bbb50107790dc09cb6f45bb9c382ca gregoryglass started the topic Sinequan®(doxepin) Oral Concentrate in the forum Safety Petitions https://fdapetitions.com/forums/topic/sinequan-doxepin-oral-concentrate/ Tue, 24 Sep 2019 17:50:49 +0000 Product: Sinequan®(doxepin) Oral Concentrate Company: PfizerPetition Filer: Hibrow HealthcarePetition Number(s): 2019P-4424Date of Petition: September 23, 2019Responding Petitions: Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Sinequan®(doxepin) Oral Concentrate (NDA 017516) was not being marketed for r…Read more

]]> d46deda24a8e9b35e51a8c2ccd604895 gregoryglass started the topic Gris-Peg®(griseofulvin) Tablets in the forum Product Petitions https://fdapetitions.com/forums/topic/gris-peg-griseofulvin-tablets-d62/ Fri, 13 Sep 2019 15:59:43 +0000 Product: Gris-Peg®(griseofulvin) Tablets Company: Valeant, MountainPetition Filer: Hyman, Phelps, a law firmPetition Number(s): 2019P-4261Date of Petition: September 3, 2019Responding Petitions: Issue and Implication: Whether FDA must designate a second Reference Standard.Action Requested by Petitioner: The Petitioner would like to submit…Read more

]]> f36361cc10fc85300763316a060108f6 gregoryglass started the topic Emend®(fosaprepitant) Injection in the forum Product Petitions https://fdapetitions.com/forums/topic/emend-fosaprepitant-injection-d97/ Tue, 10 Sep 2019 15:20:14 +0000 Product: Emend®(fosaprepitant) Injection Company: Merck/TevaPetition Filer: TevaPetition Number(s): 2019P-4155Date of Petition: September 6, 2019Responding Petitions: Issue and Implication: Whether FDA must issue A ratings to 505(b)(2) NDA products that are similar to the reference list drug.Action Requested by Petitioner: The Petitioner is…Read more

]]> 752cefbf3fe31abc6e8d73c99cc54902 gregoryglass started the topic Samsca®(tolvaptan) Tablets (Jynarque) in the forum Product Petitions https://fdapetitions.com/forums/topic/samsca-tolvaptan-tablets-jynarque/ Tue, 27 Aug 2019 11:57:18 +0000 Product: Samsca®(tolvaptan) Tablets (Jynarque)
Company: Otuska
Petition Filer: Otuska
Petition Number(s): 2019P-4002
Date of Petition: August 26, 2019
Responding Petitions:

Issue and Implication: Whether FDA must apply the same REMS restrictions to a product with the same active ingredient but is not the same as the REMS…Read more

]]> cea4573e753cf04deffc6727b2adbe92 gregoryglass started the topic Vasostrict®(vasopressin) Injection in the forum Suitability Petitions https://fdapetitions.com/forums/topic/vasostrict-vasopressin-injection-d0/ Thu, 22 Aug 2019 17:28:49 +0000 Product: Vasostrict®(vasopressin) Injection
Company: Par
Petition Filer: AuroMedics
Petition Number(s): 2019P-3934
Date of First Petition: August 21, 2019
Responding Petitions:

Action Requested of Petition: The Petitioner would like to submit an ANDA and manufacture vasopressin injection of 20 units per mL (10 mL fill volume). This…Read more

]]> 930c0083e588ae07fad997123586f32b gregoryglass started the topic Lidocaine Oral Solution 2% in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/lidocaine-oral-solution-2/ Wed, 21 Aug 2019 14:23:07 +0000 Product: Lidocaine Oral Solution 2%
Company: Various
Petition Filer: Hymen Phelps, a law firm
Petition Number(s): 2019P-3903
Date of Petition: August 20, 2019
Responding Petitions:

Issue and Implication: Whether FDA is required to designate a Reference Standard when the current Reference Standard is apparently not available.

Action…Read more

]]> 760685061a09bf9a92d31488c30ccb95 gregoryglass started the topic Glucophage®(metformin) Tablets in the forum Safety Petitions Archives http://fdapetitions.com/forums/topic/glucophage-metformin-tablets-d35/ Wed, 21 Aug 2019 14:11:29 +0000 Product: Glucophage®(metformin) Tablets
Company: Bristol Myers Squibb
Petition Filer: Harman Finochem
Petition Number(s): 2019P-3877
Date of Petition: August 20, 2019
Responding Petitions:

Action Requested by Petitioner: The petitioner would like to FDA to determine whether Glucophage®(metformin) Tablets was removed from the market v…Read more

]]> 40cc4ec58849ee8595a56768d36521a3 gregoryglass started the topic Tenex®(guanfacine) Tablets in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/tenex-guanfacine-tablets/ Fri, 16 Aug 2019 19:36:45 +0000 Product: Tenex®(guanfacine) Tablets
Company: Promius/Amneal
Petition Filer: Hymen Phelps
Petition Number(s): 2019P-3803
Date of Petition: August 13, 2019
Responding Petitions:

Issue and Implication: Whether FDA is required to designate a Reference Standard when the current Reference Standard is apparently not available.

Action…Read more

]]> 9991a59560e6fab690a97f31aaf88bc5 gregoryglass started the topic Tegretol XR®(carbamazepine) Extended-release Tablets in the forum Product Petitions Archives http://fdapetitions.com/forums/topic/tegretol-xr-carbamazepine-extended-release-tablets/ Sun, 28 Jul 2019 17:20:55 +0000 Product: Tegretol XR®(carbamazepine) Extended-release Tablets
Company: Novartis
Petition Filer: Zydus
Petition Number(s): 2019P-3545
Date of Petition: July 26, 2019
Responding Petitions: Teva

Issue and Implication: Whether ANDA’s approved (or pending) must re-test their products if FDA issues a subsequent Draft Guidance for bi…Read more

]]> 6949ca8ba1e8fe78f90e39fb2137612e gregoryglass started the topic Nix®(permethrin) Topical Lotion in the forum Safety Petitions Archives https://fdapetitions.com/forums/topic/nix-permethrin-topical-lotion/ Sat, 06 Jul 2019 15:04:35 +0000 Product: Nix®(permethrin) Topical Lotion
Company: Glaxo Smithkline
Petition Filer: Lachman Consultants
Petition Number(s): 2019P-3232
Date of Petition: Jujly 5, 2019
Responding Petitions:

Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Nix®(permethrin) Topical Lotion (NDA 019435) was removed from t…Read more

]]> ad1e81cad3a146b3f17f5fb0046ca52d gregoryglass started the topic Neo Tect Kit®(for technetium Tc 99m depreotide) Injection in the forum Safety Petitions Archives https://fdapetitions.com/forums/topic/neo-tect-kit-for-technetium-tc-99m-depreotide-injection/ Thu, 27 Jun 2019 13:50:45 +0000 Product: Neo Tect Kit®(for technetium Tc 99m depreotide) Injection
Company: Diatide
Petition Filer: Andarix
Petition Number(s): 2019P-3082
Date of Petition: June 26, 2019
Responding Petitions:

Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Neo Tect Kit®(for technetium Tc 99m depreotide) Injection f…Read more

]]> 1d29fa7765793ee04e99d667bbd1f605 gregoryglass started the topic Januvia®(sitagliptin) Tablets in the forum Suitability Petitions Archives https://fdapetitions.com/forums/topic/januvia-sitagliptin-tablets/ Wed, 26 Jun 2019 14:24:56 +0000 Product: Januvia®(sitagliptin) Tablets
Company: Merck
Petition Filer: Foley Lardner, a law firm
Petition Number(s): 2019P-3024
Date of First Petition: June 25, 2019
Responding Petitions: None

Action Requested of Petition: The Petitioner would like to submit an ANDA for a capsule dosage form of Januvia®(sitagliptin) Tablets (NDA 0…Read more

]]> 4a90a096fa8e96311a436817336b922c gregoryglass started the topic Xarelto®(rivaroxaban) Tablets in the forum Suitability Petitions Archives https://fdapetitions.com/forums/topic/xarelto-rivaroxaban-tablets/ Wed, 26 Jun 2019 14:20:37 +0000 Product: Xarelto®(rivaroxaban) Tablets
Company: Janssen
Petition Filer: Foley Lardner, a law firm
Petition Number(s): 2019P-3022
Date of First Petition: June 25, 2019
Responding Petitions: None

Action Requested of Petition: The Petitioner would like to submit an ANDA for a capsule dosage form of Xarelto®(rivaroxaban) Tablets (NDA 0…Read more

]]> 3aace60f8189a4012e659f9289da3c17 gregoryglass started the topic Valsartan and N,N-Dimethylformamide in the forum Product Petitions https://fdapetitions.com/forums/topic/valsartan-and-n-n-dimethylformamide/ Fri, 14 Jun 2019 13:46:57 +0000 Product: Valsartan and N,N-Dimethylformamide
Company: Various
Petition Filer: Valisure
Petition Number(s): 2019P-2869
Date of Petition: June 13, 2019
Responding Petitions:

Issue and Implication: Whether current FDA standards for daily intake of a known carcinogenic is sufficient to ensure safe use of medications.

Action Requested…Read more

]]> 0d5aae4852de97e027cd8bf6b7e00a73 gregoryglass started the topic Delflex®(calcium chloride, et al) Injection in the forum Product Petitions https://fdapetitions.com/forums/topic/delflex-calcium-chloride-et-al-injection/ Fri, 14 Jun 2019 13:26:48 +0000 Product: Delflex®(calcium chloride, et al) Injection Company: Fresenius KabiPetition Filer: Fresenius KabiPetition Number(s): 2019P-2853Date of Petition: June 13, 2019Responding Petitions: Issue and Implication: Whether a product has to be listed as a Reference Standard or Reference List Drug.Action Requested by Petitioner: Petitioner is…Read more

]]> 559dda07fd8f92f8234bce22da68a05f gregoryglass started the topic Viberzi®(eluxadoline) Tablets in the forum Product Petitions https://fdapetitions.com/forums/topic/viberzi-eluxadoline-tablets/ Sat, 25 May 2019 19:33:56 +0000 Product: Viberzi®(eluxadoline) Tablets Company: AllerganPetition Filer: AllerganPetition Number(s): 2019P-2537Date of Petition: May 24, 2019Responding Petitions: Issue and Implication: Whether current FDA standards for an ANDA establishing bioequivalence is sufficient for locally-acting drugs.Action Requested by Petitioner: The Petitioner…Read more

]]> 14469ee64142baad26ab94992c4501ba gregoryglass started the topic Depot Medroxyprogesterone Acetate and COC’s in the forum Product Petitions https://fdapetitions.com/forums/topic/depot-medroxyprogesterone-acetate-and-coc-s/ Sat, 11 May 2019 14:48:35 +0000 Product: Depot Medroxyprogesterone Acetate and COC’s
Company: Various
Petition Filer: Contraceptive Study Group
Petition Number(s): 2019P-2289
Date of Petition: May 10, 2019
Responding Petitions:

Issue and Implication: Whether post-marketing surveillance is sufficient to ensure continued safe use of products on the market.

Action R…Read more

]]> b4262dd8937f3a603e5a5af96fd70ecd gregoryglass started the topic Efudex®(fluorouracil) Solution in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/efudex-fluorouracil-solution/ Sat, 11 May 2019 14:33:03 +0000 Product: Efudex®(fluorouracil) Solution
Company: Valeant
Petition Filer: Encube
Petition Number(s): 2019P-2074
Date of Petition: May 10, 2019
Responding Petitions:

Issue and Implication: Whether FDA must list a drug as a Reference List Drug.

Action Requested by Petitioner: The petitioner is asking FDA to designate the Taro…Read more

]]> c97a3a46af006a9d3144cd782737c63c gregoryglass started the topic Oxitriptan in the forum Product Petitions https://fdapetitions.com/forums/topic/oxitriptan/ Fri, 03 May 2019 12:29:52 +0000 Product: Oxitriptan Company: Various, APIPetition Filer: Summit Health PharmacyPetition Number(s): 2019P-2088Date of Petition: May 2, 2019Responding Petitions: Issue and Implication: Whether a compound used for a certain disease for decades qualifies it for compounding under the 503A Bulks List.Action Requested by Petitioner: The Petitioner…Read more

]]> 60c947d76ef9ef0a9ca112e0e33e0067 gregoryglass started the topic Levophed®(norephinephrine) Injection in the forum Suitability Petitions https://fdapetitions.com/forums/topic/levophed-norephinephrine-injection/ Thu, 02 May 2019 13:38:51 +0000 Product: Levophed®(norephinephrine) Injection Company: HospiraPetition Filer: TechReg ServicesPetition Number(s): 2019P-2070Date of First Petition: May 1, 2019Responding Petitions: NoneAction Requested of Petition: “The undersigned requests that the Commissioner of the Food and Drug Administration determine whether the drug product No…Read more

]]> 0ec8502934cc83d82013ca01fef9d20d gregoryglass started the topic Entresto®(sacubitril/valsartan) Tablets in the forum Product Petitions https://fdapetitions.com/forums/topic/entresto-sacubitril-valsartan-tablets/ Sat, 20 Apr 2019 15:09:45 +0000 Product: Entresto®(sacubitril/valsartan) Tablets
Company: Novartis
Petition Filer: Novartis
Petition Number(s): 2019P-1893
Date of Petition: April 19, 2019
Responding Petitions:

Issue and Implication: Whether FDA Guidance regarding a showing of product sameness for an ANDA filer is sufficient to ensure product sameness.

Action…Read more

]]> 46eaf784b795928f4b96189ac4984dec gregoryglass started the topic Prolia®(denosumab) Injection in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/prolia-denosumab-injection/ Thu, 18 Apr 2019 13:31:54 +0000 Product: Prolia®(denosumab) Injection
Company: Amgen
Petition Filer: Public Citizen
Petition Number(s): 2019P-1818
Date of Petition: April 17, 2019
Responding Petitions: Amgen

Issue and Implication: Whether additional evidence regarding the safety profile of a drug merits changes to the label.

Action Requested by Petitioner: The…Read more

]]> 9088aeab0f474daa5fef0bfc773e98b5 gregoryglass started the topic Neostigmine Methylsulphate Injection in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/neostigmine-methylsulphate-injection/ Sat, 06 Apr 2019 18:40:54 +0000 Product: Neostigmine Methylsulphate Injection
Company: Fresenius Kabi
Petition Filer: Nexsen Pruitt, a law firm
Petition Number(s): 2019P-1636
Date of Petition: April 5, 2019
Responding Petitions:

Issue and Implication: Whether FDA must list a drug as a Reference List Drug.

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

]]> 976dbb53e3b3bccb10494d5a37368a5d gregoryglass started the topic Dibenzyline®(phenoxybenzamine) Capsules in the forum Product Petitions Archives http://fdapetitions.com/forums/topic/dibenzyline-phenoxybenzamine-capsules/ Fri, 05 Apr 2019 14:09:03 +0000 Product: Dibenzyline®(phenoxybenzamine) Capsules
Company: Concordia Pharmaceuticals
Petition Filer: Aurobindo
Petition Number(s): 2019P-1607
Date of Petition: April 4, 2019
Responding Petitions:

Issue and Implication: Whether FDA can designate a second Reference Standard.

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

]]> 5f52a31d211c46ccf8066bf0ad3fd5da gregoryglass started the topic Mifeprex®(misoprostal) Tablets in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/mifeprex-misoprostal-tablets/ Tue, 02 Apr 2019 15:11:23 +0000 Product: Mifeprex®(misoprostal) Tablets
Company: Danco Laboratories
Petition Filer: American Association of Pro-Life ObGyns
Petition Number(s): 2019P-1534
Date of Petition: April 1, 2019
Responding Petitions:

Issue and Implication: Whether the REMS programs can be revised back to its original guidelines once modified.

Action…Read more

]]> 6c3b883c088b2e46c9d69bb9957086ed gregoryglass started the topic List of Drug Bulk Substances and Compounding Pharmacies in the forum Issue Petitions https://fdapetitions.com/forums/topic/list-of-drug-bulk-substances-and-compounding-pharmacies/ Fri, 22 Mar 2019 21:53:14 +0000 Issue: List of Drug Bulk Substances and Compounding Pharmacies Petition Filer: American Association of Naturopathic Physicians (AANP)Petition Number(s): 2019P-1351Date of Petition: March 21, 2019Responding Petitions: Issue and Implication: Whether FDA can reconsider and re-write Final Rulemaking.Action Requested by Petitioner: The Petitioner…Read more

]]> bb9556d0f91152e577b3968073055cd7 gregoryglass started the topic Vimpat®(lacosamide) Oral Solution in the forum Suitability Petitions https://fdapetitions.com/forums/topic/vimpat-lacosamide-oral-solution/ Wed, 27 Feb 2019 14:53:03 +0000 Product: Vimpat®(lacosamide) Oral Solution Company: USB IncPetition Filer: Sunshine Lake Pharma CoPetition Number(s): 2019P-0915Date of First Petition: February 26, 2019Responding Petitions: NoneAction Requested of Petition: The Petitioner would like to submit an ANDA for a granules for oral solution form of lacosamide (10mg/mL). The RLD…Read more

]]> c30df9594e5ce4646f682736eaa82ef8 gregoryglass started the topic Goprelto®(cocaine) Nasal Spray in the forum Product Petitions Archives http://fdapetitions.com/forums/topic/goprelto-cocaine-nasal-spray/ Tue, 05 Feb 2019 16:13:23 +0000 Product: Goprelto®(cocaine) Nasal Spray
Company: Genus Lifesciences
Petition Filer: Genus Lifesciences
Petition Number(s): 2019P-0538
Date of Petition: February 4, 2019
Responding Petitions: Lannett

Issue and Implication: Whether an application (ANDA or 505(b)(2) filing) can be filed for five years during the New Chemical Exclusivity…Read more

]]> bd53d407758bbd9ececba6c538517b76 gregoryglass started the topic Methscopolamine Bromide Tablets in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/methscopolamine-bromide-tablets/ Tue, 05 Feb 2019 15:56:38 +0000 Product: Methscopolamine Bromide Tablets
Company: Unknown
Petition Filer: Kulkarni Law Firm
Petition Number(s): 2019P-0537
Date of Petition: February 4, 2019
Responding Petitions:

Issue and Implication: Whether an API or finished drug manufacturer must adhere to FDA Guidance.

Action Requested by Petitioner: The Petitioner is…Read more

]]> 06f927fe03b3f4b89199d2f4dd5a6d4b gregoryglass started the topic Lidocaine Transdermals in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/lidocaine-transdermals/ Wed, 30 Jan 2019 14:05:00 +0000 Product: Lidocaine Transdermals
Company: Various
Petition Filer: Scilex Pharmaceuticals
Petition Number(s): 2019P-0417
Date of Petition: January 29, 2019
Responding Petitions:

Issue and Implication: Whether a product designated as Generally Recognized as Safe (GRAS) can be required to go through the NDA review process for certain…Read more

]]> 523c7420f3efdaf1e6782897923b91dc gregoryglass started the topic Bactrim®(sulfamethoxazole and trimethophrim) Oral Suspension in the forum Product Petitions https://fdapetitions.com/forums/topic/bactrim-sulfamethoxazole-and-trimethophrim-oral-suspension/ Fri, 18 Jan 2019 18:39:43 +0000 Product: Bactrim®(sulfamethoxazole and trimethophrim) Oral Suspension
Company: Sun Pharmaceuticals
Petition Filer: NaviSci Pte Ltd
Petition Number(s): 2019P-0198
Date of Petition: January 14, 2019
Responding Petitions:

Issue and Implication: Whether FDA can designate a second Reference Standard.

Action Requested by Petitioner: The…Read more

]]> f5b0f41cc440b4c8cef92ddebc261d55 gregoryglass started the topic Ketalar®(ketamine) Injection in the forum Suitability Petitions https://fdapetitions.com/forums/topic/ketalar-ketamine-injection/ Wed, 09 Jan 2019 12:59:31 +0000 Product: Ketalar®(ketamine) Injection
Company: Par
Petition Filer: Hospira
Petition Number(s): 2019P-0114
Date of First Petition: January 8, 2019
Responding Petitions:

Action Requested of Petition: Petitioner is requesting that FDA allow it to submit an ANDA for a 200mg/2mL (100 mg/mL) dosage strength of ketamine hydrochloride…Read more

]]> f17fe848546944ce4d159d9c894dac54 gregoryglass started the topic Euthyrox®(levothyroxine) Tablets in the forum Product Petitions https://fdapetitions.com/forums/topic/euthyrox-levothyroxine-tablets/ Sat, 22 Dec 2018 17:49:31 +0000 Product: Euthyrox®(levothyroxine) Tablets
Company: Provell Pharmaceuticals
Petition Filer: Amneal
Petition Number(s): 2018P-4832
Date of Petition: December 21, 2018
Responding Petitions: Provell Pharmaceuticals

Issue and Implication: Whether a color coded tablets for a narrow therapeutic index drug is sufficient to merit an A…Read more

]]> 8aede6f64f4e95019d0828737802ecb2 gregoryglass started the topic Glyrx-PF®(glycopyrrolate) Injection in the forum Product Petitions Archives https://fdapetitions.com/forums/topic/glyrx-pf-glycopyrrolate-injection/ Tue, 18 Dec 2018 15:29:40 +0000 Product: Glyrx-PF®(glycopyrrolate) Injection
Company: Exela
Petition Filer: Exela
Petition Number(s): 2018P-4769
Date of Petition: December 17, 2018
Responding Petitions:

Issue and Implication: Whether a 505(b)(2) NDA can be AP rated to a product which is also discontinued.

Action Requested by Petitioner: The Petitioner is…Read more

]]> 7074114eb08b09da55b24098062a10c2 gregoryglass started the topic Imvexxy™(estradiol) Capsules in the forum Product Petitions https://fdapetitions.com/forums/topic/imvexxy-estradiol-capsules-2/ Fri, 14 Dec 2018 16:26:31 +0000 Product: Imvexxy™(estradiol) Capsules
Company: TherapeuticsMD
Petition Filer: TherapeuticsMD
Petition Number(s): 2018P-4714
Date of Petition: December 12, 2018
Responding Petitions: Teva

Issue and Implication: Whether an ANDA needs to do additional bioequivalent testing for a locally acting product.

Action Requested by Petitioner: …Read more

]]> a07e894ebc6b5f582fdb437bce65d11f gregoryglass started the topic Lamisil®(terbinafine) Tablets in the forum Product Petitions https://fdapetitions.com/forums/topic/lamisil-terbinafine-tablets/ Fri, 30 Nov 2018 00:48:38 +0000 Product: Lamisil®(terbinafine) Tablets
Company: Novartis/Aurobindo
Petition Filer: Unichem Pharmaceuticals
Petition Number(s): 2018P-4549
Date of Petition: November 29, 2018
Responding Petitions:

Issue and Implication: Whether FDA can designate a second Reference Standard.

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

]]> 7c16ae09332e47267ac236da08c6dded gregoryglass started the topic Tygacil®(tigecycline) Injection in the forum Suitability Petitions https://fdapetitions.com/forums/topic/tygacil-tigecycline-injection-d94/ Fri, 16 Nov 2018 17:09:41 +0000 Product: Tygacil®(tigecycline) Injection Company: PrismPetition Filer: FreyrPetition Number(s): 2018P-4340Date of First Petition: November 14, 2018Responding Petitions: NoneAction Requested of Petition: Petitioner would like FDA to determine that tigecycline for injection, 50mg/vial containing 82.6mg of arginine as a stabilizing agent. The…Read more

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