Eton Pharmaceuticals Announces U.S. FDA Approval of Biorphen (phenylephrine HCI) Injection Biorphen is the First and Only Ready-to-Use FDA-Approved Injectable Formulation of Phenylephrine Biorphen Eliminates Need for Com

Pharmaceuticals Announces U.S. FDA Approval of Biorphen (phenylephrine HCI) Injection

is the First and Only Ready-to-Use FDA-Approved Injectable Formulation of Phenylephrine

Eliminates Need for Compounding, Reducing Risks for Unsafe Injection Practices, Medication Administration Errors, Sterility Breaches,

PARK, Ill., October 22, 2019 - Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on

developing and commercializing innovative drug products, today announced that the U.S. Food and Drug Administration (FDA) has

approved Biorphen , the first and only FDA-approved ready-to-use formulation of phenylephrine for the treatment of clinically

important hypotension resulting primarily from vasodilation in the setting of anesthesia.

to the FDA approval of Biorphen, phenylephrine injection was only approved and available as a highly concentrated formulation

that required hospitals to manually dilute the concentrate prior to administration, or purchase ready-to-use formulations from

503B compounding pharmacies. Compounded drugs do not have to undergo FDA premarket review for safety, effectiveness and certain

controls over manufacturing quality. Due to this lower regulatory standard, compounded drugs are often associated with higher

risks of medication error.1

FDA approval of Biorphen addresses a critical medical need for an approved, ready-to-use standardized formulation of phenylephrine

that can potentially reduce medication administration errors and improve patient safety," said Sean Brynjelsen, chief executive

officer of Eton Pharmaceuticals. "The approval of Biorphen represents an important step forward in Eton's commitment

to improving existing medicines to address unmet patient needs. We look forward to working with our manufacturing partner, Sintetica,

to make Biorphen available to hospitals across the United States before the end of the year."

rooms, emergency departments and intensive care units are fast-paced and time-sensitive environments. Add to that the complexity

of caring for patients with a wide range of critical conditions and the use of high-alert medications like phenylephrine -

and you have an atmosphere primed for potential medication error," said Jared Marcucci, M.D., assistant director, Community

First Medical Center Department of Emergency Medicine in Chicago. "As a practicing emergency medicine physician, the availability

of an FDA-approved, ready-to-use formulation of phenylephrine is a welcome advance, providing physicians and hospital systems

with an important new option that does not require compounding and can potentially help reduce the risk of medication errors and

minimize harm to patients."

at the bedside need reliable, easy to use, safe drugs that have a consistent supply. Many hospitals outsource unapproved ready-to-use

phenylephrine from 503B compounders, however often have to navigate supply disruptions through these suppliers," said Heather

Nixon, M.D., Associate Professor Anesthesiology, University of Illinois at Chicago Hospital. "The availability of Biorphen

will help address many of the underlying causes for risk and error associated with compounded phenylephrine while also reducing

potential for waste associated with overdrawing medications. This will be an important new tool for anesthesiologists, pharmacists

and other hospital providers in their efforts to enhance patient safety and prevent patient harm."

(phenylephrine HCI) Injection is the first and only FDA-approved ready-to-use formulation of phenylephrine for treating

clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Designed for patient safety,

Biorphen can be administered without diluting, which reduces the risk of medication error in often stressful clinical environments.

No compounding also reduces the risk of sterility breach, can assist safe injection practices, and reduces waste. Ready-to-use

Biorphen can be standardized and stocked in the operating room, emergency department and intensive care unit, as well as in crash

carts throughout the hospital. Biorphen's three-year shelf life reduces the need for hospital staff to monitor and restock

it as frequently as compounded phenylephrine.

injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting

primarily from vasodilation in the setting of anesthesia.

administration of phenylephrine can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate

underlying heart failure, and increase pulmonary arterial pressure. BIORPHEN can cause excessive peripheral and visceral vasoconstriction

and ischemia to vital organs as well as severe bradycardia and decreased cardiac output.

during intravenous administration may cause necrosis or sloughing of tissue. The most common side effects of phenylephrine during

treatment are nausea, vomiting, and headache. Interactions with concomitant medications may augment or antagonize the pressor

common adverse reactions during treatment: nausea, vomiting, and headache.

of BIORPHEN (phenylephrine hydrochloride) can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting,

hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including

ventricular extrasystoles and ventricular tachycardia.

see full Prescribing Information at:

Eton Pharmaceuticals

Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative products utilizing

the FDA's 505(b)(2) regulatory pathway. Eton is primarily focused on liquid dosage forms including injectables, oral liquids

and ophthalmics. Eton has a diversified pipeline of high-value product candidates in various stages of development and therapeutic

areas, including multiple product candidates currently under review by the FDA.

contained in this press release regarding matters that are not historical facts are "forward-looking statements" within

the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability

of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited

to statements regarding Eton's business strategy, Eton's plans to develop and commercialize its product candidates,

the safety and efficacy of Eton's product candidates, Eton's plans and expected timing with respect to regulatory

filings and approvals, and the size and growth potential of the markets for Eton's product candidates. Because such statements

are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking

statements. Words such as "believes," "anticipates," "plans," "expects," "intends,"

"will," "goal," "potential" and similar expressions are intended to identify forward-looking

statements. These forward-looking statements are based upon Eton's current expectations and involve assumptions that may

never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated

in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated

with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics,

and in the endeavor of building a business around such drugs. These and other risks concerning Eton's development programs

and financial position are described in additional detail in Eton's filings with the Securities and Exchange Commission.

All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes

no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they

2018 Compounding Policy Priorities Plan. US Food and Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/2018-compounding-policypriorities-plan.

Updated June 21, 2018. Accessed May 14, 2019./para 20/line 2-9