Is This Fat-Dissolving Shot Labeled Kybella for the Chin?

Which fat-dissolving shot is this?

Across med spas, wellness lounges, and cosmetic clinics, patients are routinely presented with treatment menus advertising 'fat-dissolving injections,' 'lipo shots,' 'chin slimming,' or 'PCDC contouring.' These commercial descriptions obscure a fundamental clinical and regulatory boundary. What is being administered is never simply a generic procedure; it is a specific chemical substance drawn from a physical vial, manufactured under specific quality standards, and governed by strict legal classifications.

In the United States, injectable adipolytic products occupy four distinct regulatory categories that must never be conflated. The first category is labeled KYBELLA, the brand name for deoxycholic acid injection (10 mg/mL), which received FDA approval under New Drug Application (NDA) 206333 strictly for moderate to severe submental fat convexity in adults. The second category is unapproved extra-submental use of an approved drug—frequently called off-label Kybella—where the legitimate pharmaceutical product is administered into anatomical regions such as the abdomen, arms, flanks, or jowls without FDA evaluation of safety or efficacy. The third category encompasses unapproved lipolytic products, including Aqualyx, Lipodissolve, Lipo Lab, Kabelline, Lemon Bottle, and compounded phosphatidylcholine/deoxycholate (PCDC) mixtures, which have never undergone FDA premarket evaluation and are distributed outside lawful pharmaceutical channels. The fourth category is unverified or unknown formulations, where vials labeled vaguely as 'deoxycholic acid' lack verifiable National Drug Codes, security features, or manufacturer documentation.

This guide provides an objective, carton-level verification framework designed to help patients and injectors confirm exactly which product is on the tray before an injection takes place. It examines the verifiable text on the packaging, the presence of security features, the chemical formulation, and the intended anatomical site. Crucially, this article does not provide injection grids, 0.2 mL spacing templates, needle depth instructions, or dosing calculations, which are restricted to qualified healthcare providers operating within approved product labeling. Nor does it rank commercial clinics or evaluate whether a patient should choose injectable lipolysis over cryolipolysis or surgical liposuction.

Identity worksheet: name, NDC, hologram, body area, and unknown fields

Before consenting to any injectable fat-reduction treatment, patients can ask to see the manufacturer packaging. The following worksheet records eight verification fields from the carton, insert, or menu. Every row is a labeled fictional offer—not a real patient, an actual lot, a clinic ranking, or a census of what menus contain. The rows show how to classify a KYBELLA carton used under the chin, extra-submental use of that same approved carton, an unapproved Lipo Lab, Kabelline, or Aqualyx name, an unmatched deoxycholic-acid name, a leftover two-vial KYBELLA pack, and an ANDA 212296 generic that still needs documentation.

Interpreting the worksheet means filling each column from the carton, insert, or menu, and leaving a field unknown when it is blank. The standards below are DailyMed and FDA identity rules, not a clinic ranking and not an injection protocol.

1. Trade Name and Labeler Code

For a labeled-KYBELLA mark, the trade name printed on the outer carton still has to match DailyMed: kybella (deoxycholic acid) injection 10 mg/mL. DailyMed lists the packager as Kythera Biopharmaceuticals Inc., with distribution by AbbVie Inc. The KYBELLA labeler code is 61168. The four-vial carton is NDC 61168-101-04, with inner vial NDC 61168-101-01. DailyMed also lists a two-vial carton, NDC 61168-101-03, with a marketing start date of 1 August 2018 and no marketing end date on that pack row; the inner vial NDC is not separately coded on that pack-3 row. A carton NDC of 61168-101-94/61168-101-91 has a marketing end date of 30 January 2022. A name that is not KYBELLA, and that lacks NDA 206333 or ANDA 212296 documentation, is not converted into KYBELLA by a menu that says 'Kybella' or 'fat-dissolving shot.'

2. Security Hologram Authentication

DailyMed How Supplied states that KYBELLA has a unique hologram on the vial label; if you do not see a hologram, do not use the product and call 1-800-678-1605. That instruction is a KYBELLA carton field. It does not describe the hologram's appearance, and it does not assign a hologram to ANDA 212296 or to unapproved names. A vial claiming to be KYBELLA without a hologram is not a verified labeled-KYBELLA carton.

3. 'Do Not Dilute' and Single-Patient Handling

DailyMed carton and How Supplied language for KYBELLA includes: Single use vials. Discard unused portion; Four ready-to-use vials; Do not dilute; and Do not dilute or mix KYBELLA with other compounds. Each vial is for a single patient use. Those sentences are identity and handling fields for a labeled KYBELLA carton. They are not a mixing protocol, and they are not evidence of how Aqualyx, Lipo Lab, Kabelline, or PCDC kits are typically prepared. DailyMed lists benzyl alcohol among inactive ingredients; that listing does not convert a KYBELLA vial into a multi-patient vial.

4. Planned Anatomical Injection Site

The worksheet requires recording the planned body area. Adult submental fat (fat below the chin) is the labeled indication on current DailyMed. Abdomen, arms, thighs, or other extra-submental sites are not labeled indications. That site field is what keeps extra-submental use of an approved carton from being marked as labeled submental use, and it is not a dose table.

What the KYBELLA carton and label actually say

Drugs@FDA lists KYBELLA, deoxycholic acid, 20 mg/2 mL (10 mg/mL), solution for subcutaneous use, NDA 206333, company ABBVIE, original approval 29 April 2015. Current DailyMed (label updated 30 October 2024; Highlights Revised 10/2024; Patient Information Revised 10/2024; SPL version 25 published 31 December 2025) is the carton and patient-information source for this worksheet. The 2022 FDA-hosted PI (NDA 206333/S-005) restates the same submental indication and limitation of use; its PDF header states it may not be the latest approved label.

Under Section 1 (Indications and Usage), the DailyMed prescribing information states: 'KYBELLA is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.' Immediately beneath this sentence, the label establishes a formal Limitation of Use: 'The safe and effective use of KYBELLA for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.' The accompanying FDA-approved Patient Information leaflet (revised October 2024) reinforces this warning in accessible language: 'It is not known if KYBELLA is safe and effective for the treatment of fat outside of the submental area. It is not known if KYBELLA is safe and effective in children under 18 years of age.'

DailyMed How Supplied and Description identify KYBELLA as a clear, colorless, sterile 10 mg/mL solution in 2 mL single-patient-use vials. Each 2 mL vial contains 20 mg synthetic deoxycholic acid (UNII 005990WHZZ). Inactive ingredients listed per 2 mL vial are benzyl alcohol 18 mg, dibasic sodium phosphate 2.84 mg, sodium chloride 8.76 mg, sodium hydroxide 2.86 mg, water for injection, and hydrochloric acid as needed to pH 8.3. Mechanism of action on the label is limited: when injected into tissue, KYBELLA physically destroys the cell membrane causing lysis. DailyMed pharmacokinetics notes that endogenous deoxycholic acid is a product of cholesterol metabolism. Those identity fields do not make extra-submental use a labeled indication, and they do not convert an Aqualyx, Lipo Lab, or PCDC name into KYBELLA.

DailyMed section 14 describes two identical-design randomized, multicenter, double-blind, placebo-controlled trials in healthy adults ages 19 to 65, BMI ≤ 40 kg/m², with moderate or severe submental convexity. Combined, 514 subjects received KYBELLA and 508 placebo, up to 6 treatments at no less than 1-month intervals. Co-primary endpoints were at least 2-grade and at least 1-grade improvements on the composite of clinician-reported and patient-reported submental-fat ratings 12 weeks after final treatment. Trial 1 2-grade composite response: 13.4% KYBELLA versus <0.1% placebo; 1-grade: 70.0% versus 18.6%. Trial 2 2-grade: 18.6% versus 3.0%; 1-grade: 66.5% versus 22.2%. MRI subset: at least 10% reduction in submental fat volume in 43% versus 5%. Those studies support the submental indication only. They are not evidence that extra-submental use is labeled, and they are not a head-to-head with Aqualyx, Lipo Lab, or PCDC.

The prescribing information outlines serious contraindications and adverse reactions that dictate strict anatomical boundaries. KYBELLA is absolutely contraindicated in the presence of active infection at the proposed injection sites. Section 5 (Warnings and Precautions) highlights substantial risks inherent to cytolytic action:

• Marginal Mandibular Nerve Injury: DailyMed section 5.1 reports cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness (paresis). All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1–298 days, median 44 days). Table 1 lists nerve injury (marginal mandibular nerve paresis) in 4% (20 of 513) of KYBELLA-treated subjects versus <1% placebo. Those figures are labeled trial counts, not a how-to map of the exclusion zone.

• Dysphagia (Difficulty Swallowing): DailyMed section 5.2 states that difficulty swallowing (dysphagia) occurred in clinical trials in the setting of administration-site reactions such as pain, swelling, and induration of the submental area, and that cases spontaneously resolved (range 1–81 days, median 3 days). Table 1 lists dysphagia in 2% (10 of 513) of KYBELLA-treated subjects versus <1% placebo. Section 2.2 directs clinicians to screen for other potential causes of submental fullness, including thyromegaly and cervical lymphadenopathy. Section 5.4 warns against injecting in close proximity to salivary glands, lymph nodes, and muscles.

• Injection Site Hematoma and Bleeding: Injection site hematoma or bruising occurred in 72% of treated subjects. Clinicians must exercise extreme caution in patients receiving antiplatelet or anticoagulant therapies.

• Injection Site Ulceration, Necrosis, and Infection: DailyMed section 5.6, added as a Highlights warning in the October 2022 S-005 labeling, is injection site ulceration, necrosis, and infection. It states that injections that are too superficial (into the dermis) may result in skin ulceration and necrosis, and that some infection cases included cellulitis and abscess requiring intravenous antibiotics and incision and drainage. Vascular injury is a separate labeled issue: section 5.4 warns that inadvertent injection into an artery or vein can result in vascular injury, and postmarketing experience lists vascular injury due to inadvertent intravascular injection. Those sentences are safety-boundary fields. They are not an injection grid.

DailyMed Table 1 (pooled Trials 1 and 2; KYBELLA N=513) lists the most common injection-site reactions as edema/swelling 87%, hematoma/bruising 72%, pain 70%, numbness 66%, erythema 27%, and induration 23%. Highlights summarize the most common adverse reactions (>20%) as injection site edema/swelling, hematoma, pain, numbness, erythema, and induration. Those labeled rates apply to the studied submental use. They are not incidence rates for Aqualyx or PCDC, and they are not a ranked clinic list.

Same approved drug, different body area

Menus sometimes offer authentic KYBELLA, or an FDA-approved generic deoxycholic acid injection, for body areas other than adult submental fat—jowls, abdomen, arms, or thighs. If the carton is still KYBELLA or documented ANDA 212296, that is not proof the vial is Aqualyx. It is also not labeled submental use. What identity does that offer occupy?

On FDA's patient page, this practice constitutes unapproved use of an approved drug, colloquially termed 'off-label' use. As explained in the FDA's patient page Understanding Unapproved Use of Approved Drugs 'Off Label', once FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient. Unapproved use includes use for a condition the drug is not approved to treat, giving it in a different way, or giving it in a different dose.

Off-label legality of a physician's prescription is not an identity field that converts the carton into 'FDA-approved for the body.' FDA's patient page states that when a drug is prescribed for its approved use, FDA has evaluated benefits and risks for that use and there is approved labeling on how to use it for that use. DailyMed's limitation of use remains: the safe and effective use of KYBELLA for subcutaneous fat outside the submental region has not been established and is not recommended. Advertising extra-submental treatment as 'FDA-approved Kybella for the stomach' or 'FDA-cleared arm contouring' is not supported by the labeled indication.

Those extra-submental risks prompted a later labeling action. On September 15, 2026, the FDA issued a major Drug Safety Communication titled 'FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use.' The safety alert announced approved labeling modifications in the Warnings and Precautions section regarding severe adverse reactions associated with extra-submental administration and formally reiterated that the FDA recommends against this unapproved use.

The September 2026 communication says FDA approved the revised labeling after review of FAERS reports—now known as the FDA Adverse Event Monitoring System—and the medical literature. Key findings include:

• 129 Extra-Submental Adverse Event Cases: Since Kybella's approval in 2015, FDA identified 129 cases of adverse events when deoxycholic acid injection was used in areas of the body outside the approved site. Those are FAERS-and-literature case counts, not incidence rates, and not findings about unapproved Aqualyx or PCDC products.

• Severe Neuromuscular and Ocular Injuries: FDA states that when Kybella is administered outside the submental fat region, neuromuscular and other serious adverse events may occur. Patients should be aware of serious events reported with injection at sites other than under the chin, including blurred or reduced vision, involuntary eye contractions, muscle and nerve damage and weakness, numbness, and difficulty walking. Some serious extra-submental events include blurred or reduced vision with periorbital use and muscle or nerve injury including facial paresis and paresthesia. The communication does not convert those case descriptions into a body-area dosing table.

• Persistent Injection Site Nodules and Masses: FDA also approved Warnings and Precautions language on injection site nodules (3 cm or smaller) and masses (larger than 3 cm), which may not resolve over time and may require medical intervention. FDA identified 117 cases of unresolved nodules or masses, present for a mean of 143 days at the time of reporting. Nodules and masses may occur with labeled submental use and with extra-submental use. The communication does not specify which interventions were used, and those 117 cases are not Aqualyx injury rates.

A publication lag matters for carton inspection: DailyMed Highlights still read Revised 10/2024 and do not yet reprint the 15 September 2026 extra-submental and nodule/mass warning block. The Drug Safety Communication is the source for that labeling-warning action. Do not treat the 10/2024 revision date as proof the new sentences are already on every insert, and do not invent that the fetched SPL already contains them.

Unapproved names are not Kybella

Off-label use of approved deoxycholic acid is not the same identity as an unapproved injection. A separate bucket is products FDA has not approved as drugs: names such as Aqualyx, Lipodissolve, Lipo Lab, Kabelline, Lemon Bottle, Lipo Vela, Super V-Line Sol, Neobella Extreme, and Deoxycholic Acid Booster.

The FDA addressed this dangerous category directly in a public safety communication titled Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful (current as of 20 December 2023). FDA states that unapproved fat-dissolving injections are marketed and sold online under brand names such as Aqualyx, Lipodissolve, Lipo Lab, Kabelline, and others; that sellers have claimed their products reduce fat deposits in areas such as the chin, back, thighs, upper arms, and stomach; and that common ingredients include phosphatidylcholine (PPC) and sodium deoxycholate (DC), used alone or together and sometimes called PCDC injections. Those ingredients pose a significant safety risk because they are unapproved, which means FDA has not evaluated their safety or effectiveness. The 2023 page's sentence that Kybella is the only FDA-approved fat-dissolving injectable is older than the 15 September 2026 communication, which states that a generic deoxycholic acid injection is also FDA-approved and that Kybella and that generic are the only drugs approved for that submental indication. Keep both dates. The 2023 page remains the named-brand list for unapproved products and the self-injection warning.

Lemon Bottle is a different ingredient story from PCDC. Fox Pharma pages quoted in the 3 March 2025 warning letter claimed riboflavin, bromelain, and lecithin fat-decomposition uses. Keep Lemon Bottle in the unapproved-lipolytic bucket without collapsing it into phosphatidylcholine/sodium deoxycholate. FDA has not approved it under section 505.

Federal regulatory enforcement escalated dramatically on March 3, 2025, when the FDA issued formal Warning Letters to online distributors marketing injectable lipolytic products into the United States:

• Fox Pharma LLC (Warning Letter MARCS-CMS 699225): The FDA cited Fox Pharma for introducing unapproved new drugs into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic (FD&C) Act. The agency specifically identified LemonBottle Ampoule Solution, Lipo Lab PPC Solution (brown vial), Lipo Lab PPC Solution, Lipo Vela, Lipo Lab V-Line, Kabelline, and Super V-Line Sol as illegal unapproved drugs with no approved section 505 applications in effect.

• Vivid-Scientific LLC (Warning Letter MARCS-CMS 699226): The FDA cited Vivid-Scientific for marketing LemonBottle Ampoule Solution, Lipo Lab PPC Solution, Neobella Extreme, and a product labeled 'Deoxycholic Acid Booster' as unapproved new drugs lacking required premarket applications.

Wholesale and clinic pages sometimes treat Aqualyx as a CE-marked alternative that is 'used off-label' in the United States. That phrasing collapses an unapproved product into off-label use of an approved drug. FDA's off-label page and the 2023 unapproved-injections page keep those identities apart. No EU notified-body certificate is cited here, so this page does not assert a current Aqualyx CE status. A CE mark or online listing is not FDA approval. An unapproved product has no approved U.S. drug label, so it cannot be 'off-label KYBELLA.'

FDA's unapproved-injections page states that FDA has received reports of permanent scars, serious infections, skin deformities, cysts, and deep, painful knots after unapproved injections, including at clinics or med spas and after consumers purchased the drugs online and injected themselves. Consumers should not purchase ingredients for unapproved fat-dissolving injections or inject the drugs themselves. Those reports are FDA-received reports, not incidence rates, and they are about unapproved injections rather than labeled KYBELLA trial counts.

Generic deoxycholic acid is not a third mystery shot

Secondary consumer pages still sometimes say no lower-cost generic is available. Drugs@FDA and the Orange Book still list ANDA 212296 as Prescription/AP. Absence of a DailyMed generic SPL is not a finding that the ANDA was withdrawn, and ANDA approval is not a clinic-stock census.

On April 2, 2021, the FDA approved Abbreviated New Drug Application (ANDA) 212296 for Deoxycholic Acid Injection, 20 mg/2 mL (10 mg/mL) single-dose vials under section 505(j) of the FD&C Act. The 2 April 2021 approval letter is addressed to Slayback Pharma LLC. Drugs@FDA currently lists the company as WILSHIRE PHARMS INC. In the Orange Book / therapeutic-equivalence table, ANDA 212296 is assigned TE code AP. For this injectable solution, AP means FDA has evaluated it as therapeutically equivalent to the reference listed drug, KYBELLA (NDA 206333). That application-number identity is not a leftover-vial census.

FDA's 2021 First Generic Drug Approvals table lists ANDA 212296 with RLD Kybella and indication 'For improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.' In its 15 September 2026 Drug Safety Communication, FDA states that a generic deoxycholic acid injection product is also FDA-approved and that Kybella and that generic are the only drugs FDA-approved for that submental indication.

Distinguishing an approved generic carton from an unmatched 'deoxycholic acid' name still requires documentation. As of 16 September 2026, Drugs@FDA notes that the ANDA 212296 label is not available on that site, and a DailyMed human-label search for deoxycholic acid returned the KYBELLA SPL and did not return a Wilshire or Slayback generic SPL. Absence of a hosted generic SPL is not proof the ANDA was withdrawn. Because no generic carton text was retrieved, hologram, NDC, and do-not-dilute fields for a generic vial remain unknown unless ANDA 212296 documentation is in hand. A carton that says only 'deoxycholic acid' without KYBELLA NDC 61168, hologram, or ANDA 212296 documentation stays unknown. A seller name such as 'Deoxycholic Acid Booster' is not ANDA 212296.

The 3 March 2025 Vivid-Scientific warning letter names Deoxycholic Acid Booster as an unapproved new drug with no approved section 505 application. That seller name is not KYBELLA and is not ANDA 212296. When name, NDC, hologram, or application number is blank, the honest mark is unknown, and this page does not choose a product or a body area.

What this page does not decide

To maintain absolute patient safety and editorial integrity, this article establishes explicit clinical and technical boundaries regarding what it does and does not decide:

• No Injection Grids or Administration Protocols: This guide deliberately omits the labeled 0.2 mL injection grid, 1 cm injection spacing templates, needle depth instructions, and marginal mandibular nerve exclusion zones described in Section 2 of the KYBELLA prescribing information. Providing administration protocols in a patient verification article creates dangerous self-treatment risks. Technique and anatomical localization must be executed exclusively by licensed, trained medical injectors.

• No Dosage Calculations or Session Schedules: This article does not calculate how many vials or treatment sessions an individual patient requires. Dosage is strictly determined by physical palpation of the submental preplatysmal fat pad and patient-specific anatomical boundaries during an in-person medical evaluation.

• No Commercial Clinic Rankings or Menu Surveys: This guide does not endorse, rate, or survey commercial med spas, dermatology practices, or cosmetic surgery centers. It provides a universal verification worksheet applicable to any clinical setting.

• No Modality Outcome Guarantees: This article does not evaluate whether injectable deoxycholic acid is clinically superior to submental cryolipolysis (CoolSculpting) or micro-cannula tumescent liposuction for a specific individual.

Readers evaluating facial aesthetics and body contouring decisions are encouraged to consult our focused clinical companions:

• Fat-Dissolving Injections Beyond Kybella: Aqualyx, Lipo Lab, and Gray Market Safety: For a comprehensive clinical encyclopedia examining the pharmacology, infection risks, and regulatory history of unapproved lipolytic cocktails.

• Kybella Side Effects: Nerve Injury, Dysphagia, and What the Label and FDA Reports Show: For a detailed anatomical analysis of marginal mandibular nerve pathways, swallowing complications, and recovery timelines.

• Kybella safety: what 1,968 FDA FAERS reports reveal: For an examination of postmarket adverse event reports, reporting trends, and serious complication frequencies in the FDA FAERS database.

• Kybella vs CoolSculpting for a Double Chin: Cost, Results, Risks: For a head-to-head analysis comparing cytolytic injection with submental cryolipolysis in terms of discomfort, downtime, and tissue response.

• Kybella vs Chin Liposuction: Recovery, Cost, and Candidacy: For clinical decision guidance distinguishing chemical adipolysis from surgical micro-liposuction for moderate to severe submental fullness.

• FDA-Approved Chin Fillers: Voluma, Defyne, and Lyft vs Implant, Kybella, and Volux: For structural evaluation of whether submental fullness is exacerbated by retrogenia, requiring structural projection rather than fat dissolution.

• Which Hyaluronidase Vial Is This: Hylenex, Vitrase, or Other?: For dissolve-enzyme vial identity, a different worksheet from this fat-dissolving carton map.

• Off-Label Aesthetic Treatment Consent: Documenting Risk Clearly: For consent documentation of unapproved use, not a carton-identity table.

• Counterfeit Botox and Fillers — How to Verify Your Injector Uses Authentic Products: For toxin and filler authenticity checks, not a KYBELLA versus Aqualyx identity map.

Sources

1. DailyMed: KYBELLA (deoxycholic acid) injection, solution. U.S. National Library of Medicine. Set ID fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553. Label updated October 30, 2024; Highlights Revised 10/2024; Patient Information Revised 10/2024; current SPL version 25 published December 31, 2025.

2. KYBELLA (deoxycholic acid) injection prescribing information, NDA 206333/S-005. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Approved October 2022.

3. Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful. U.S. Food and Drug Administration. Consumer Health Information. Content current as of December 20, 2023.

4. Understanding Unapproved Use of Approved Drugs "Off Label". U.S. Food and Drug Administration. Patient Information on Off-Label Prescribing. Content current as of February 5, 2018.

5. FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use. U.S. Food and Drug Administration. FDA Drug Safety Communication. Issued September 15, 2026.

6. Drugs@FDA: KYBELLA (NDA 206333). U.S. Food and Drug Administration. Application details for deoxycholic acid subcutaneous solution, AbbVie Inc. Original approval April 29, 2015.

7. Drugs@FDA: Deoxycholic Acid (ANDA 212296). U.S. Food and Drug Administration. Application details for deoxycholic acid subcutaneous solution, WILSHIRE PHARMS INC. Original approval April 2, 2021; therapeutic equivalence code AP.

8. ANDA 212296 approval letter, Deoxycholic Acid Injection, 20 mg/2 mL (10 mg/mL). U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Formal approval letter to Slayback Pharma LLC, April 2, 2021.

9. 2021 First Generic Drug Approvals. U.S. Food and Drug Administration, Office of Generic Drugs. Annual first generic drug approvals record, listing ANDA 212296.

10. Fox Pharma LLC warning letter MARCS-CMS 699225, March 3, 2025. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter regarding unapproved injectable lipolytic new drugs.

11. Vivid-Scientific LLC warning letter MARCS-CMS 699226, March 3, 2025. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter regarding unapproved new drug marketing.