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Monday, June 20, 2022
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FDA Authorizes Pfizer and Moderna COVID-19 Vaccines for Children


In this Issue

•  IVIG/Albumin Supply Index
•  Open Market Pricing
•  New Products from FFF
•  Current Medicare
•  Resources
•  Subscribe to IG Living and BioSupply Trends Quarterly
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The U.S. Food and Drug Administration (FDA) has authorized emergency use of the Moderna COVID-19 and Pfizer-BioNTech COVID-19 vaccines for the prevention of the SARS-CoV-2 virus to include use in children as young as 6 months of age. read more ]


New Flu Vaccine Effective Against Multiple Virus Strains

Researchers at Monash University in Australia and the National University of Singapore have developed an influenza (flu) vaccine containing the M2e peptide that is able to trigger long-lasting immune responses against multiple flu virus strains. read more ]

Monkeypox Vaccine Being Released from U.S. National Stockpile

The United States is responding to a request for the release of monkeypox vaccine from the nation’s Strategic National Stockpile as a global outbreak of cases is under investigation. read more ]

Study Shows Possibility of a Universal Vaccine Effective Against New SARS-CoV-2 Variants

A study conducted at the University of California, Los Angeles suggests certain immune cells can be used to eventually create a universal vaccine effective against new variants of SARS-CoV-2. Specifically, it showed that there is a component of SARS-CoV-2 that is consistent among all variants — its viral polymerase — and by targeting that portion of the virus with T cells, a longer-lasting immunity can be achieved. read more ]

Industry News

Industry News Image

From Pfizer and BioNTech

The U.S. Food and Drug Administration amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine, authorizing the use of a single booster dose for administration to individuals 5 years through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 vaccine. read more ]

From U.S. Food and Drug Administration (FDA)

FDA is warning people not to use the Skippack Medical Lab SARS-CoV-2 antigen rapid test, Colloidal Gold, because it is not authorized, cleared or approved by FDA for distribution or use in the United States. FDA is concerned about the risk of false results when using this test because SML Distribution LLC has not provided FDA with adequate data to show the test works correctly. read more ]

From Roivant Sciences

Vtama is now approved by the U.S. Food and Drug Administration to treat plaque psoriasis, making the drug the first novel topical treatment for the chronic autoimmune disorder in a generation. read more ]

From Regeneron Pharmaceuticals

The U.S. Food and Drug Administration has approved Dupixent (dupilumab) to treat eosinophilic esophagitis, a chronic immune disease, in adults and pediatric patients 12 years and older weighing at least 40 kilograms (approximately 88 pounds). read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand

What's New at FFF


ADRENALIN (epinephrine injection) is a non-selective alpha and beta adrenergic agonist indicated for emergency treatment of allergic reactions (type 1), including anaphylaxis; and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. It is supplied in a carton containing 25 3 mL single-dose vials containing 1 mg/mL Adrenalin solution.

For more information about ADRENALIN, log in to


EPSOLAY (benzoyl peroxide cream) is indicated for the treatment of inflammatory lesions of rosacea in adults. It is supplied in an airless 30 gram pump.

For more information about EPSOLAY, log in to


VTAMA (tapinarof) cream 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. It is supplied in 60 gram laminated tubes.

For more information about VTAMA, log in to


SEVENFACT (coagulation factor VIIa [recombinant]-jncw) is a concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors. It is supplied as a room-temperature stable, white to off-white, lyophilized powder in single-use 1 mg or 5 mg vials, one vial per carton. The 1 mg vial is packaged with a pre-filled syringe containing 1.1 mL of sterile water for injection to reconstitute the diluent and one 13 mm vial adapter with a 5 micron filter. The 5 mg vial is packaged with a pre-filled syringe containing 5.2 mL of sterile water for injection to reconstitute the diluent and one 20 mm vial adapter with a 5 micron filter.

For more information about SEVENFACT, log in to


PACLITAXEL protein-bound particles for injectable suspension (albumin¬ bound) is a microtubule inhibitor indicated for the treatment of: 1) metastatic disease or relapse within six months of adjuvant chemo¬therapy (prior therapy should have included an anthracycline unless clinically contraindicated), 2) locally advanced or metastatic non-small cell lung cancer, as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy and 3) metastatic adenocarcinoma of the pancreas as first-line treat¬ment, in combination with gemcitabine. It is supplied in a 100 mg single-dose vial individually packaged in a carton.

For more information about PACLITAXEL, log in to


PREHEVBRIO (hepatitis B vaccine [recombinant]) is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. It is supplied in a 1.0 mL single-dose vial, or in a package of 10 single dose-vials.

For more information about PREHEVBRIO, log in to


TWYNEO CREAM (tretinoin and benzoyl peroxide) is a combination of tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. It is supplied in a 30-gram bottle with a pump.

For more information about TWYNEO CREAM, log in to


CLINDAMYCIN PHOSPHATE AND TRETINION Gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older. It is supplied in 30 g and 60 g aluminum tubes.

For more information about CLINDAMYCIN PHOSPHATE AND TRETINION GEL, log in to


ACTHAR GEL (repository corticotropin injection) is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age; for the treatment of exacerbations of multiple sclerosis in adults; and may be used for the following disorders and diseases: rheumatic, collagen, dermatologic, allergic states, ophthalmic, respiratory and edematous state. It is supplied in a 5 mL multi-dose vial containing 80 USP units per mL.

For more information about ACTHAR GEL, log in to


VAZCULEP (phenylephrine hydrochloride) 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. It is supplied in a strength of 10 mg/mL in a 1 mL single-use vial in packages of 10, a 5 mL vial in packages of 10 and a 10 mL vial as a single unit.

For more information about VAZCULEP, log in to


TRANEXAMIC ACID in sodium chloride injection is indicated in patients with hemophilia for short-term use (i.e., 2-8 days) to reduce/prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. It is supplied as a sterile, unpreserved, colorless solution in a single-dose polymeric bag containing 1,000 mg tranexamic acid in 100 mL of solution (10 mg/mL) sealed with a twist-off port and oversealed in an aluminum pouch.

For more information about TRANEXAMIC ACID, log in to


GLYRX-PF is an anticholinergic indicated in 1) anesthesia (adult and pediatric patients) for reduction of airway or gastric secretions, and volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation; intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias; and for protection against peripheral muscarinic effects of cholinergic agents; and 2) in peptic ulcer (adults) as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated. It is supplied in 1 mL single-dose (0.2 mg/mL) vials packaged in 25s and 2 mL single-dose (0.4 mg/2 mL) vials packaged in 25s.

For more information about GLYRX-PF, log in to


CAFFEINE CITRATE ORAL SOLUTION is indicated for the short-term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. It is supplied as a clear, color¬less, sterile, non-pyrogenic, preservative-free, aqueous solution in 5 mL colorless glass vials containing 3 mL solution at a concentration of 20 mg/mL caffeine citrate (60 mg/vial) equivalent to 10 mg/mL caffeine base (30 mg/vial).

For more information about CAFFEINE CITRATE ORAL SOLUTION, log in to


VERAPAMIL is indicated for the treatment of supraventricular tachyarrhythmias, including 1) Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes); and 2) temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation, except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (WPW and LGL syndromes). It is supplied in 5 mg (2 mL) vials in a carton of five; 5 mg (2 mL) vials in a carton of 25; and 10 mg (4 mL) vials in a carton of five.

For more information about VERAPAMIL, log in to


NIPRIDE RTU sodium nitroprusside injection is a direct acting vasodilator indicated for immediate reduction of blood pressure; producing controlled hypotension to reduce bleeding during surgery; and treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. It is supplied in amber-colored, single-dose, 50 mg/100 mL (0.5 mg/mL) fliptop vials, 20 mg/100 mL (0.2 mg/mL) fliptop vials and 10 mg/50 mL (0.2 mg/mL) fliptop vials.

For more information about NIPRIDE RTU, log in to


METHYLENE BLUE injection is used to treat methemoglobinemia (a blood disorder in which an abnormal amount of methemoglobin is produced). It is supplied in 10 mL single-dose vials.

For more information about METHYLENE BLUE, log in to


LANREOTIDE injection is a somatostatin analog indicated for 1) the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy; and 2) the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival. It is supplied in strengths of 60 mg/0.2 mL, 90 mg/0.3 mL and 120 mg/0.5 mL in single-dose prefilled syringes.

For more information about LANREOTIDE, log in to


SENSORCAINE (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. It is supplied in 10 mL (2.5 mg/mL, 5 mg/mL and 7.5 mg/mL) and 30 mL (2.5 mg/mL and 5 mg/mL) single-dose vials in trays of 25, as well as 30 mL (2.5 mg/mL and 5 mg/mL) single-dose vials packaged in 5.

For more information about SENSORCAINE, log in to


ALBUTEIN 5% (human) is an albumin solution indicated for hypovolemia, cardiopulmonary bypass procedures, hypoalbuminemia and plasma exchange. It is supplied in an easy-to-use, flexible container.

For more information about ALBUTEIN FLEXBAG 5%, log in to


PYRIMETHAMINE TABLETS 25 mg are indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination. They are supplied as tablets, each containing 25 mg pyrimethamine in bottles of 100 (NDC 47781-925-01) and 30 (NDC 47781-925-30) and in 30-count unit-dose blister cartons (NDC 47781-925-31).

For more information about PYRIMETHAMINE TABLETS, log in to


VAXELIS is a three-dose vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years old. It is supplied in a single-dose vial in packages of 10 and a 0.5 mL single-dose prefilled syringe with a Luer lock connection and a tip cap without a needle in packages of 10.

For more information about VAXELIS, log in to

These products can be ordered from FFF Enterprise's BioSupply Online Ordering System or by calling
Wow! Customer Care at (800) 843-7477.

Current Medicare IVIG / SCIG Rates

Rates per gram are effective April 1, 2022, through June 30, 2022.

Calculate Your Current Medicare IVIG/SCIG Rates
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
ASCENIV J1554 $963.54 $948.09
BIVIGAM J1556 $140.98 $138.72
FLEBOGAMMA DIF J1572 $77.43 $76.19
GAMMAGARD SD J1566 $139.85 $137.61
GAMMAPLEX J1557 $101.47 $99.84
OCTAGAM J1568 $83.64 $82.30
PANZYGA 90283 / J1599 $150.27 $147.86
PRIVIGEN J1459 $90.10 $88.66
CUTAQUIG 90284 / J3590 $127.68 $125.63
CUVITRU J1555 $147.40 $145.04
HIZENTRA J1559 $117.87 $115.98
HYQVIA J1575 $152.47 $150.02
XEMBIFY J1558 $136.57 $134.38
GAMMAGARD LIQUID J1569 $87.76 $86.35
GAMMAKED J1561 $86.08 $84.70
GAMUNEX-C J1561 $86.08 $84.70

*ASP + 4.3% applies only after July 1, 2022. On April 1, 2022, a 1% reduction in payment will apply until July 1, 2022, unless further Congressional action is taken to extend the moratorium.



FFF customers may order the following complementary resources to help you with your practice:

Seasonal Flu Poster flu myths and facts brochure
immune globulin reference charts
•  IG Immune Globulin (Human)
•  Hyperimmune Globulins
•  Anti-Inhibitor, Factor VIIa & IX
•  Factor VIII & von Willebrand Factor
•  Seasonal Influenza Vaccine

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