83 FR 58257 - Determination That REGITINE (Phentolamine Mesylate) Injection, 5 Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 223 (November 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 223 (November 19, 2018)
| Page Range | 58257-58259 | |
| FR Document | 2018-25187 |
[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)] [Notices] [Pages 58257-58259] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25187] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4142] Determination That REGITINE (Phentolamine Mesylate) Injection, 5 Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ``listed drug,'' which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ``Approved Drug Products With Therapeutic Equivalence Evaluations,'' which is generally known as the ``Orange Book.'' Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table are no longer being marketed. -------------------------------------------------------------------------------------------------------------------------------------------------------- Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant -------------------------------------------------------------------------------------------------------------------------------------------------------- NDA 008278......................... REGITINE.............. Phentolamine Mesylate. 5 milligrams (mg)/ Injectable; Injection Novartis vial. Pharmaceuticals Corp. NDA 011287......................... KAYEXALATE............ Sodium Polystyrene 453.6 grams (g)/ Powder; Oral, Rectal. Concordia Sulfonate. bottle. Pharmaceuticals, Inc. NDA 011751......................... PROLIXIN.............. Fluphenazine 2.5 mg/milliliter Injectable; Bristol-Myers Squibb Hydrochloride (HCl). (mL). Injection;. Co. Fluphenazine HCl...... 1 mg; 2.5 mg; 5 mg; Tablet; Oral......... 10 mg. NDA 012249......................... LIBRIUM............... Chlordiazepoxide HCl.. 5 mg; 10 mg; 25 mg... Capsule; Oral........ Valeant Pharmaceuticals North America, LLC. NDA 016008......................... PERMITIL.............. Fluphenazine HCl...... 5 mg/mL.............. Concentrate; Oral.... Schering Corp., Subsidiary of Schering Plough, Corp. NDA 016110......................... PROLIXIN ENANTHATE.... Fluphenazine Enanthate 25 mg/mL............. Injectable; Injection Bristol-Myers Squibb Co. NDA 017007......................... HEPARIN SODIUM........ Heparin Sodium........ 1,000 units/mL; 2,500 Injectable; Injection West-Ward units/mL; 5,000 Pharmaceuticals units/mL; 7,500 International, Ltd. units/mL; 10,000 units/mL; 15,000 units/mL; 20,000 units/mL; 5,000 units/0.5 mL;. NDA 017105......................... TRANXENE.............. Clorazepate 3.75 mg; 7.5 mg; 15 Tablet; Oral;........ Recordati Rare TRANXENE.............. Dipotassium. mg. Capsule; Oral;....... Diseases, Inc. TRANXENE SD........... Clorazepate 3.75 mg; 7.5 mg; 15 Tablet; Oral......... Dipotassium. mg. Clorazepate 11.25 mg; 22.5 mg.... Dipotassium. NDA 017488......................... MODICON 21............ Ethinyl Estradiol; 0.035 mg; 0.5 mg..... Tablet; Oral......... Ortho-McNeil Norethindrone. Pharmaceutical, Inc. [[Page 58258]] NDA 017489......................... ORTHO-NOVUM 1/35-21... Ethinyl Estradiol; 0.035 mg; 1 mg....... Tablet; Oral......... Ortho-McNeil Norethindrone. Pharmaceutical, Inc. NDA 017575......................... DTIC-DOME............. Dacarbazine........... 100 mg/vial; 200 mg/ Injectable; Injection Bayer Healthcare vial. Pharmaceuticals, Inc. NDA 017576......................... OVCON-50.............. Ethinyl Estradiol; 0.05 mg; 1 mg........ Tablet; Oral......... Warner Chilcott Co., Norethindrone. LLC. NDA 017619......................... LOTRIMIN.............. Clotrimazole.......... 1%................... Cream; Topical....... Schering Plough Healthcare Products, Inc. NDA 017831......................... DIDRONEL.............. Etidronate Disodium... 200 mg; 400 mg....... Tablet; Oral......... Allergan Pharmaceuticals International, Ltd. NDA 018017......................... BLOCADREN............. Timolol Maleate....... 5 mg; 10 mg; 20 mg... Tablet; Oral......... Merck & Co., Inc. NDA 018052......................... GYNE-LOTRIMIN......... Clotrimazole.......... 1%................... Cream; Vaginal....... Bayer HealthCare, LLC. NDA 018148......................... NASALIDE.............. Flunisolide........... 0.025 mg/spray....... Metered Spray; Nasal. IVAX Research, Inc. ANDA 018551........................ POTASSIUM IODIDE...... Potassium Iodide...... 1 g/mL............... Solution; Oral....... Roxane Laboratories, Inc. NDA 019004......................... ORTHO-NOVUM 7/14-28... Ethinyl Estradiol; 0.035 mg/0.5 mg; Tablet; Oral......... Ortho-McNeil ORTHO-NOVUM 7/14-21... Norethindrone. 0.035 mg/1 mg. Pharmaceutical, Inc. Ethinyl Estradiol; 0.035 mg/0.5 mg; Norethindrone. 0.035 mg/1 mg. NDA 019309......................... VASOTEC............... Enalaprilat........... 1.25 mg/mL........... Injectable; Injection Biovail Laboratories International SRL. NDA 019621......................... VENTOLIN.............. Albuterol Sulfate..... Equivalent to (EQ) 2 Syrup; Oral.......... GlaxoSmithKline. mg base/5 mL. NDA 019847......................... CIPRO................. Ciprofloxacin......... 400 mg/40 mL; 200 mg/ Injectable; Injection Bayer Healthcare 20 mL; 1200 mg/120 Pharmaceuticals, mL. Inc. NDA 019857......................... CIPRO IN DEXTROSE 5% Ciprofloxacin......... 200 mg/100 mL; 400 mg/ Injectable; Injection Bayer Healthcare IN PLASTIC CONTAINER. 200 mL. Pharmaceuticals, Inc. NDA 019972......................... OCUPRESS.............. Carteolol HCl......... 1%................... Solution/Drops; Novartis Ophthalmic. Pharmaceuticals, Corp. NDA 020107......................... NOVAMINE 15% SULFITE Amino Acids........... 15%.................. Injectable; Injection Baxter Healthcare, FREE IN PLASTIC Corp. CONTAINER. NDA 020207......................... ALKERAN............... Melphalan HCl......... EQ 50 mg base/vial... Injectable; Injection Apotex, Inc. NDA 020261......................... LESCOL................ Fluvastatin Sodium.... EQ 20 mg base; EQ 40 Capsule; Oral........ Novartis mg base. Pharmaceuticals, Corp. NDA 020264......................... MEGACE................ Megestrol Acetate..... 40 mg/mL............. Suspension; Oral..... Bristol-Myers Squibb Co. NDA 020363......................... FAMVIR................ Famciclovir........... 125 mg; 250 mg; 500 Tablet; Oral......... Novartis mg. Pharmaceuticals, Corp. NDA 020792......................... CARDIZEM.............. Diltiazem HCl......... 100 mg/vial.......... Injectable; Injection Biovail Laboratories, Inc. NDA 021127......................... OPTIVAR............... Azelastine HCl........ 0.05%................ Solution/Drops; Mylan Specialty, L.P. Ophthalmic. NDA 021178......................... GLUCOVANCE............ Glyburide; Metformin 2.5 mg/500 mg; 5 mg/ Tablet; Oral......... Bristol-Myers Squibb HCl. 500 mg. Co. NDA 21277.......................... AVELOX IN SODIUM Moxifloxacin HCl...... 400 mg/250 mL........ Solution; IV Infusion Bayer HealthCare CHLORIDE 0.8% IN Pharmaceuticals, PLASTIC CONTAINER. Inc. NDA 021406......................... FORTICAL.............. Calcitonin Salmon 200 international Metered Spray; Nasal. Upsher-Smith Recombinant. units/spray. Laboratories, LLC. NDA 021530......................... MOBIC................. Meloxicam............. 7.5 mg/5 mL.......... Suspension; Oral..... Boehringer Ingelheim Pharmaceuticals, Inc. NDA 021689......................... NEXIUM IV............. Esomeprazole Sodium... EQ 20 mg base/vial... Injectable; AstraZeneca Intravenous. Pharmaceuticals LP. NDA 022033......................... LUVOX CR.............. Fluvoxamine Maleate... 100 mg; 150 mg....... Extended-Release Jazz Pharmaceuticals, Capsule; Oral. Inc. NDA 050299......................... NILSTAT............... Nystatin.............. 100,000 units/mL..... Suspension; Oral..... Glenmark Generics Inc., USA. NDA 050484......................... CERUBIDINE............ Daunorubicin HCl...... EQ 20 mg base/vial... Injectable; Injection Wyeth Research. NDA 050662......................... BIAXIN................ Clarithromycin........ 250 mg; 500 mg....... Tablet; Oral......... AbbVie, Inc. ANDA 060076........................ STREPTOMYCIN SULFATE.. Streptomycin Sulfate.. EQ 1g base/vial; EQ 5 Injectable; Injection Pfizer, Inc. g base/vial. [[Page 58259]] ANDA 080472........................ HYTONE................ Hydrocortisone........ 1%, 2.5%............. Cream; Topical....... Valeant Pharmaceuticals North America, LLC. ANDA 080473........................ HYTONE................ Hydrocortisone........ 1%; 2.5%............. Lotion; Topical...... Valeant Pharmaceuticals North America, LLC. ANDA 080474........................ HYTONE................ Hydrocortisone........ 1%, 2.5%............. Ointment; Topical.... Dermik Laboratories, Inc. NDA 202088......................... SUPRENZA.............. Phentermine HCl....... 15 mg; 30 mg; 37.5 mg Orally Disintegrating Citius Tablet; Oral. Pharmaceuticals, LLC. -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA has reviewed its records and, under Sec. 314.161, has determined that the drug products listed were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products in the ``Discontinued Drug Product List'' section of the Orange Book. The ``Discontinued Drug Product List'' identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs and ANDAs listed are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: November 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-25187 Filed 11-16-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices 58257
and thus is not a regulatory action for that FDA will not begin procedures to 355(j)(7)), which requires FDA to
the purposes of E.O. 13771. withdraw approval of abbreviated new publish a list of all approved drugs.
In accordance with the provisions of drug applications (ANDAs) that refer to FDA publishes this list as part of the
Executive Order 12866, this notice was these drug products, and it will allow ‘‘Approved Drug Products With
reviewed by the Office of Management FDA to continue to approve ANDAs that Therapeutic Equivalence Evaluations,’’
and Budget. refer to the products as long as they which is generally known as the
Dated: October 19, 2018. meet relevant legal and regulatory ‘‘Orange Book.’’ Under FDA regulations,
requirements. a drug is removed from the list if the
Seema Verma,
Administrator, Centers for Medicare & FOR FURTHER INFORMATION CONTACT: Agency withdraws or suspends
Medicaid Services. Stacy Kane, Center for Drug Evaluation approval of the drug’s NDA or ANDA
[FR Doc. 2018–25012 Filed 11–16–18; 8:45 am] and Research, Food and Drug for reasons of safety or effectiveness, or
BILLING CODE 4120–01–P
Administration, 10903 New Hampshire if FDA determines that the listed drug
Ave., Bldg. 51, Rm. 6236, Silver Spring, was withdrawn from sale for reasons of
MD 20993–0002, 301–796–8363, safety or effectiveness (21 CFR 314.162).
DEPARTMENT OF HEALTH AND Stacy.Kane@fda.hhs.gov. Under § 314.161(a) (21 CFR
HUMAN SERVICES SUPPLEMENTARY INFORMATION: In 1984, 314.161(a)), the Agency must determine
Congress enacted the Drug Price whether a listed drug was withdrawn
Food and Drug Administration Competition and Patent Term from sale for reasons of safety or
[Docket No. FDA–2018–N–4142]
Restoration Act of 1984 (Pub. L. 98–417) effectiveness: (1) Before an ANDA that
(the 1984 amendments), which refers to that listed drug may be
Determination That REGITINE authorized the approval of duplicate approved, (2) whenever a listed drug is
(Phentolamine Mesylate) Injection, 5 versions of drug products approved voluntarily withdrawn from sale and
Milligrams/Vial, and Other Drug under an ANDA procedure. ANDA ANDAs that refer to the listed drug have
Products Were Not Withdrawn From applicants must, with certain been approved, and (3) when a person
Sale for Reasons of Safety or exceptions, show that the drug for petitions for such a determination under
Effectiveness which they are seeking approval 21 CFR 10.25(a) and 10.30. Section
contains the same active ingredient in 314.161(d) provides that if FDA
AGENCY: Food and Drug Administration, the same strength and dosage form as
determines that a listed drug was
HHS. the ‘‘listed drug,’’ which is a version of
withdrawn from sale for safety or
ACTION: Notice. the drug that was previously approved.
effectiveness reasons, the Agency will
ANDA applicants do not have to repeat
SUMMARY: The Food and Drug initiate proceedings that could result in
the extensive clinical testing otherwise
Administration (FDA or Agency) has necessary to gain approval of a new the withdrawal of approval of the
determined that the drug products listed drug application (NDA). ANDAs that refer to the listed drug.
in this document were not withdrawn The 1984 amendments include what FDA has become aware that the drug
from sale for reasons of safety or is now section 505(j)(7) of the Federal products listed in the table are no longer
effectiveness. This determination means Food, Drug, and Cosmetic Act (21 U.S.C. being marketed.
Applica- Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
tion No.
NDA REGITINE ..................... Phentolamine Mesylate 5 milligrams (mg)/vial .... Injectable; Injection ....... Novartis Pharma-
008278. ceuticals Corp.
NDA KAYEXALATE ............... Sodium Polystyrene 453.6 grams (g)/bottle ... Powder; Oral, Rectal ..... Concordia Pharma-
011287. Sulfonate. ceuticals, Inc.
NDA PROLIXIN ...................... Fluphenazine Hydro- 2.5 mg/milliliter (mL) ...... Injectable; Injection; ...... Bristol-Myers Squibb
011751. chloride (HCl). 1 mg; 2.5 mg; 5 mg; 10 Tablet; Oral ................... Co.
Fluphenazine HCl .......... mg.
NDA LIBRIUM ........................ Chlordiazepoxide HCl ... 5 mg; 10 mg; 25 mg ..... Capsule; Oral ................ Valeant Pharmaceuticals
012249. North America, LLC.
NDA PERMITIL ...................... Fluphenazine HCl .......... 5 mg/mL ........................ Concentrate; Oral .......... Schering Corp., Sub-
016008. sidiary of Schering
Plough, Corp.
NDA PROLIXIN ENANTHATE Fluphenazine Enanthate 25 mg/mL ...................... Injectable; Injection ....... Bristol-Myers Squibb
016110. Co.
NDA HEPARIN SODIUM ....... Heparin Sodium ............ 1,000 units/mL; 2,500 Injectable; Injection ....... West-Ward Pharma-
017007. units/mL; 5,000 units/ ceuticals International,
mL; 7,500 units/mL; Ltd.
10,000 units/mL;
15,000 units/mL;
20,000 units/mL;
5,000 units/0.5 mL;.
NDA TRANXENE ................... Clorazepate 3.75 mg; 7.5 mg; 15 mg Tablet; Oral; .................. Recordati Rare Dis-
khammond on DSK30JT082PROD with NOTICES
017105. TRANXENE ................... Dipotassium. 3.75 mg; 7.5 mg; 15 mg Capsule; Oral; ............... eases, Inc.
TRANXENE SD ............. Clorazepate 11.25 mg; 22.5 mg ........ Tablet; Oral ...................
Dipotassium.
Clorazepate
Dipotassium.
NDA MODICON 21 ................ Ethinyl Estradiol; 0.035 mg; 0.5 mg .......... Tablet; Oral ................... Ortho-McNeil Pharma-
017488. Norethindrone. ceutical, Inc.
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![Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices 58259
Applica- Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
tion No.
ANDA HYTONE ....................... Hydrocortisone .............. 1%, 2.5% ....................... Cream; Topical .............. Valeant Pharmaceuticals
080472. North America, LLC.
ANDA HYTONE ....................... Hydrocortisone .............. 1%; 2.5% ....................... Lotion; Topical ............... Valeant Pharmaceuticals
080473. North America, LLC.
ANDA HYTONE ....................... Hydrocortisone .............. 1%, 2.5% ....................... Ointment; Topical .......... Dermik Laboratories,
080474. Inc.
NDA SUPRENZA ................... Phentermine HCl ........... 15 mg; 30 mg; 37.5 mg Orally Disintegrating Citius Pharmaceuticals,
202088. Tablet; Oral. LLC.
FDA has reviewed its records and, Food, Drug, and Cosmetic Act (FD&C and the status of other studies or
under § 314.161, has determined that Act), FDA is required to report annually clinical trials conducted on an
the drug products listed were not on the status of postmarketing applicant’s own initiative are not
withdrawn from sale for reasons of requirements (PMRs) and postmarketing required to be reported under
safety or effectiveness. Accordingly, the commitments (PMCs) required of, or §§ 314.81(b)(2)(vii) and 601.70 and are
Agency will continue to list the drug agreed upon by, application holders of not addressed in this report.
products in the ‘‘Discontinued Drug approved drug and biological products. Furthermore, section 505(o)(3)(E) of the
Product List’’ section of the Orange The report on the status of the studies FD&C Act (21 U.S.C. 355(o)(3)(E))
Book. The ‘‘Discontinued Drug Product and clinical trials that applicants have requires that applicants report
List’’ identifies, among other items, drug agreed to, or are required to, conduct is periodically on the status of each
products that have been discontinued on the FDA’s ‘‘Postmarketing required study or clinical trial and each
from marketing for reasons other than Requirements and Commitments: study or clinical trial ‘‘otherwise
safety or effectiveness. Reports’’ web page (https:// undertaken . . . to investigate a safety
Approved ANDAs that refer to the www.fda.gov/Drugs/ issue . . .’’
NDAs and ANDAs listed are unaffected GuidanceCompliance An applicant must report on the
by the discontinued marketing of the RegulatoryInformation/Post-marketing progress of the PMR/PMC on the
products subject to those NDAs and PhaseIVCommitments/ucm064436.htm). anniversary of the drug product’s
ANDAs. Additional ANDAs that refer to FOR FURTHER INFORMATION CONTACT: approval1 until the PMR/PMC is
these products may also be approved by Cathryn C. Lee, Center for Drug completed or terminated and FDA
the Agency if they comply with relevant Evaluation and Research, Food and determines that the PMR/PMC has been
legal and regulatory requirements. If Drug Administration, 10903 New fulfilled or that the PMR/PMC is either
FDA determines that labeling for these Hampshire Ave., Bldg. 22, Rm. 6484, no longer feasible or would no longer
drug products should be revised to meet Silver Spring, MD 20993–0002, 301– provide useful information.
current standards, the Agency will 796–0700; or Stephen Ripley, Center for II. Fiscal Year 2017 Report
advise ANDA applicants to submit such Biologics Evaluation and Research,
labeling. With this notice, FDA is announcing
Food and Drug Administration, 10903
the availability of the Agency’s annual
Dated: November 13, 2018. New Hampshire Ave., Bldg. 71, Rm.
report entitled ‘‘Report on the
Leslie Kux, 7301, Silver Spring, MD 20993–0002,
Performance of Drug and Biologics
Associate Commissioner for Policy.
240–402–7911.
Firms in Conducting Postmarketing
SUPPLEMENTARY INFORMATION: Requirements and Commitments.’’
[FR Doc. 2018–25187 Filed 11–16–18; 8:45 am]
BILLING CODE 4164–01–P I. Background Information in this report covers any
Section 506B(c) of the FD&C Act (21 PMR/PMC that was established, in
U.S.C. 356b(c)) requires FDA to publish writing, at the time of approval or after
DEPARTMENT OF HEALTH AND approval of an application or a
an annual report on the status of
HUMAN SERVICES supplement to an application, and
postmarketing study commitments that
applicants have committed to, or are summarizes the status of PMRs/PMCs in
Food and Drug Administration fiscal year (FY) 2017 (i.e., as of
required to conduct, and for which
[Docket No. FDA–2018–N–3771] annual status reports have been September 30, 2017). Information
submitted. summarized in the report reflects
Report on the Performance of Drug Under §§ 314.81(b)(2)(vii) and 601.70 combined data from the Center for Drug
and Biologics Firms in Conducting (21 CFR 314.81(b)(2)(vii) and 601.70), Evaluation and Research and the Center
Postmarketing Requirements and applicants of approved drugs and for Biologics Evaluation and Research
Commitments; Availability licensed biologics are required to submit and includes the following: (1) The
annually a report on the status of each number of applicants with open PMRs/
AGENCY: Food and Drug Administration,
clinical safety, clinical efficacy, clinical PMCs; (2) the number of open PMRs/
HHS.
pharmacology, and nonclinical PMCs; (3) the timeliness of applicant
ACTION: Notice of availability. submission of the annual status reports
toxicology study or clinical trial either
SUMMARY: The Food and Drug required by FDA (PMRs) or that they
khammond on DSK30JT082PROD with NOTICES
1 An applicant must submit an annual status
Administration (FDA or Agency) is have committed to conduct (PMCs), report on the progress of each open PMR/PMC
announcing the availability of the either at the time of approval or after within 60 days of the anniversary date of U.S.
Agency’s annual report entitled ‘‘Report approval of their new drug application, approval of the original application or on an
on the Performance of Drug and abbreviated new drug application, or alternate reporting date that was granted by FDA in
writing. Some applicants have requested and been
Biologics Firms in Conducting biologics license application. The status granted by FDA alternate annual reporting dates to
Postmarketing Requirements and of PMCs concerning chemistry, facilitate harmonized reporting across multiple
Commitments.’’ Under the Federal manufacturing, and production controls applications.
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Document Created: 2018-11-17 02:46:58
Document Modified: 2018-11-17 02:46:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, [email protected] | |
| FR Citation | 83 FR 58257 |
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