30962 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 

develop and disseminate productspecific guidances and provide a 

meaningful opportunity for the public to 

consider and comment on those 

guidances. Under that process, draft 

guidances are posted on FDA’s website 

and announced periodically in the 

Federal Register. The public is 

encouraged to submit comments on 

those recommendations within 60 days 

of their announcement in the Federal 

Register. FDA considers any comments 

received and either publishes final 

guidances or publishes revised draft 

guidances for comment. Guidances were 

last announced in the Federal Register 

on February 18, 2022 (87 FR 9366). This 

notice announces draft product-specific 

guidances, either new or revised, that 

are posted on FDA’s website. 

II. Drug Products for Which New Draft 

Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

new draft product-specific guidances for 

industry for drug products containing 

the following active ingredients: 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS

Active ingredient(s) 

Arsenic trioxide. 

Acetaminophen. 

Asenapine. 

Bupivacaine. 

Cedazuridine; Decitabine. 

Chlorhexidine gluconate. 

Cocaine hydrochloride. 

Exenatide synthetic (multiple referenced listed drugs). 

Flunisolide. 

Halobetasol propionate. 

Hydrocortisone; Neomycin sulfate; Polymyxin 

B sulfate. 

Ibuprofen. 

Lorezepam. 

Naloxone hydrochloride. 

Oliceridine. 

Palbociclib. 

Pralsetinib. 

Risdiplam. 

Secretin synthetic human. 

Solifenacin succinate. 

Tegaserod maleate. 

Torsemide. 

Triheptanoin. 

III. Drug Products for Which Revised 

Draft Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

revised draft product-specific guidances 

for industry for drug products 

containing the following active 

ingredients: 

TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG

PRODUCTS

Active ingredient(s) 

Acarbose. 

Doxorubicin hydrochloride. 

Linaclotide. 

Metoprolol succinate. 

Midostaurin. 

Oseltamivir phosphate. 

Selinexor. 

Solifenacin succinate. 

Theophylline. 

Tiopronin. 

Torsemide. 

Trametinib dimethyl sulfoxide. 

Uridine triacetate. 

For a complete history of previously 

published Federal Register notices 

related to product-specific guidances, go 

to https://www.regulations.gov and 

enter Docket No. FDA–2007–D–0369. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the current 

thinking of FDA on, among other things, 

the product-specific design of BE 

studies to support ANDAs. They do not 

establish any rights for any person and 

are not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

IV. Paperwork Reduction Act of 1995 

FDA tentatively concludes that these 

draft guidances contain no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

V. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https:// 

www.regulations.gov. 

Dated: May 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10701 Filed 5–19–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0766] 

Hospira, Inc., et al.; Withdrawal of 

Approval of 21 Abbreviated New Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 21 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The applicants 

notified the Agency in writing that the 

drug products were no longer marketed 

and requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

June 21, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 040140 ......... Diphenhydramine Hydrochloride (HCl) Injection, 50 milligrams (mg)/milliliters (mL).Hospira, Inc., 275 North Field Dr., Building H1–3S, Lake 

Forest, IL 60045. 

ANDA 040578 ......... Benzphetamine HCl Tablets, 50 mg ..................................... ScinoPharm Taiwan, Ltd., 909 N Ford Ave., Fullerton, CA 

92832. 

ANDA 065267 ......... Cefprozil Tablets, 250 mg, and 500 mg ................................ Bionpharma Inc., 600 Alexander Rd., Suite 2–4B, Princeton, NJ 08540. 

ANDA 065284 ......... Cefprozil Oral Suspension, 125 mg/5 mL and 250 mg/5 mL Do. 


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Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 30963 

Application No. Drug Applicant 

ANDA 065301 ......... Cefadroxil Tablets, Equivalent to (EQ) 1 gram (g) base ...... Do. 

ANDA 065307 ......... Cefadroxil Oral Suspension, EQ 250 mg base/5 mL and 

EQ 500 mg base/5 mL.

Do. 

ANDA 065309 ......... Cefadroxil Capsules, EQ 500 mg base ................................. Do. 

ANDA 065326 ......... Cephalexin Oral Suspension, EQ 125 mg base/5 mL and 

EQ 250 mg base/5 mL.

Do. 

ANDA 076720 ......... Morphine Sulfate Extended Release Tablets, 30 mg, and 

60 mg.

Nesher Pharmaceuticals (USA) LLC., 13910 Saint Charles 

Rock Rd., Bridgeton, MO 63044. 

ANDA 076733 ......... Morphine Sulfate Extended Release Tablets, 15 mg ........... Do. 

ANDA 077855 ......... Morphine Sulfate Extended Release Tablets, 100 mg and 

200 mg.

Do. 

ANDA 080225 ......... Potassium Chloride Injection, 2 milliequivalent (mEq)/mL 

and 3 mEq/mL.

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. 

ANDA 202393 ......... Diclofenac Sodium Topical Solution, 1.5% ........................... TWi Pharmaceuticals, Inc., 536 Vanguard Way, Brea, CA 

92821. 

ANDA 203581 ......... Glyburide Tablets, 1.25 mg, 2.5 mg, and 5 mg .................... Sunny Pharmtech Inc., 175 SW 166th Ave., Pembroke 

Pines, FL 33027. 

ANDA 204137 ......... Omeprazole and Sodium Bicarbonate Capsules, 20 mg; 1.1 

g.

Unicorn Pharmaceuticals, 5 Links Circle, Durham, NC 

27707. 

ANDA 206588 ......... Dextroamphetamine Sulfate Tablets, 5 mg, and 10 mg ....... Nesher Pharmaceuticals (USA) LLC. 

ANDA 208263 ......... Doxycycline Hyclate Capsules, EQ 50 mg base and EQ 

100 mg base.

Do. 

ANDA 209111 ......... Dextroamphetamine Sulfate Extended Release Capsules, 5 

mg, 10 mg, and 15 mg.

Do. 

ANDA 210079 ......... Oxycodone and Acetaminophen Tablets, 325 mg; 2.5 mg, 

325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10 mg.

Do. 

ANDA 210080 ......... Dextroamphetamine Saccharate, Amphetamine Aspartate, 

Dextroamphetamine Sulfate, and Amphetamine Sulfate 

Extended Release Capsules, 1.25 mg; 1.25 mg; 1.25 

mg; 1.25 mg, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg, 3.75 mg; 

3.75 mg; 3.75 mg; 3.75 mg, 5 mg; 5 mg; 5 mg; 5 mg, 

6.25 mg; 6.25 mg; 6.25 mg; 6.25 mg, 7.5 mg; 7.5 mg; 

7.5 mg; 7.5 mg.

Do. 

ANDA 211543 ......... Butalbital, Acetaminophen, and Caffeine Tablets, 325 mg; 

50 mg; 40 mg.

Do. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of June 21, 2022. 

Approval of each entire application is 

withdrawn, including any strengths and 

dosage forms inadvertently missing 

from the table. Introduction or delivery 

for introduction into interstate 

commerce of products without 

approved new drug applications 

violates section 301(a) and (d) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 331(a) and (d)). Drug 

products that are listed in the table that 

are in inventory on June 21, 2022, may 

continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: May 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10924 Filed 5–19–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0277] 

Risk Management Plans To Mitigate 

the Potential for Drug Shortages; Draft 

Guidance for Industry; Availability; 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Risk 

Management Plans to Mitigate the 

Potential for Drug Shortages.’’ This draft 

guidance is intended to help 

stakeholders develop, maintain, and 

implement, as appropriate, risk 

management plans (RMPs) to 

proactively assist in the prevention of 

human drug product and biological 

product shortages. In March 2020, with 

the enactment of the Coronavirus Aid, 

Relief, and Economic Security Act 

(CARES Act), the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) was 

amended to require certain 

manufacturers to develop, maintain, and 

implement, as appropriate, a 

‘‘redundancy risk management plan.’’ 

This draft guidance provides 

information about the development and 

content of RMPs for those 

manufacturers as well as for other 

stakeholders. This draft guidance 

recommends a framework and factors to 

consider that stakeholders can use to 

develop RMPs. This draft guidance is 

relevant for all stakeholders, including 

those with oversight and control 

responsibilities for drug quality and 

contract establishments, and for 

manufacturers of active pharmaceutical 

ingredients (APIs), approved or licensed 

drug and biological products, and drug 

products marketed without an 

application. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 19, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

July 19, 2022. 


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