Berinert is a human plasma-derived, purified, pasteurized, lyophilized concentrate of C1 esterase inhibitor to be reconstituted for intravenous administration. Berinert is prepared from large pools of human plasma from US donors. One standard unit of C1 esterase inhibitor concentrate is equal to the amount of C1 esterase inhibitor in 1 mL of fresh citrated human plasma, which is equivalent to 270 mg/L or 2.5 ?M/L. No international laboratory standard for quantifying C1 esterase inhibitor exists. An in-house standard is used to assure lot-to-lot consistency in product potency.

CAVERJECT Sterile Powder contains alprostadil as the naturally occurring form of prostaglandin E1 (PGE1) and is designated chemically as (11?,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.

FORADIL® CERTIHALER® (formoterol fumarate inhalation powder) is a breath-actuated multi-dose dry powder inhaler, which contains a powder formulation of formoterol fumarate intended for oral inhalation only. Each actuation of FORADIL CERTIHALER delivers approximately 8.5 mcg of formoterol fumarate from the mouthpiece (based on in vitro testing at 60 L/min for 2 sec), corresponding to a metered dose of 10 mcg of formoterol fumarate. The weight of the formulation metered is approximately 5.6 mg. Ten mcg of formoterol fumarate metered is equivalent to 8.2 mcg of formoterol base. The delivered inhalation powder also contains lactose monohydrate (which contains trace levels of milk proteins) and magnesium stearate.

ATryn (recombinant lyophilized powder) for Injection is a nanofiltered, sterile, terminally heat treated, lyophilized dosage form. Antithrombin (Recombinant), active ingredient of ATryn, is a recombinant human antithrombin. It is a 432 amino acid glycoprotein with a molecular weight of approximately 57,215 Daltons. The molecular formula is: C2191H3457N583O656S18. Antithrombin (Recombinant) is produced by recombinant DNA technology using genetically engineered goats into which the DNA coding sequence for human antithrombin has been introduced along with a mammary gland specific DNA sequence, which directs the expression of the antithrombin into the milk. The goats in which antithrombin (Recombinant) is produced are USDA certified scrapie-free, and controlled for specific pathogens.

VIOKASE® (pancrelipase, USP) is a pancreatic enzyme concentrate of porcine origin containing standardized lipase, protease, and amylase as well as other pancreatic enzymes. VIOKASE® (pancrelipase tablets, powder) is available in tablet and powder dosage form for oral administration.

D-mannitol (referred to throughout as mannitol), the active ingredient in ARIDOL (mannitol inhalation powder) is a hexahydric alcohol, that is a sugar alcohol, with the following chemical name (2R,3R,4R,5R)-hexane-1,2,3,4,5,6?­hexol and chemical structure:

Budesonide, the active component of PULMICORT FLEXHALER (budesonide inhalation powder) , is a corticosteroid designated chemically as (RS)-11?, 16?, 17,21-Tetrahydroxypregna-1,4-diene-3,20dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is:

FORADIL® AEROLIZER® (formoterol fumarate inhalation powder) consists of a capsule dosage form containing a dry powder formulation of FORADIL (formoterol fumarate) intended for oral inhalation only with the AEROLIZER Inhaler.

CINRYZE (c1 esterase inhibitor human freeze dried powder) (C1 esterase inhibitor [Human]) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE (c1 esterase inhibitor human freeze dried powder) is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. The specific activity of CINRYZE (c1 esterase inhibitor human freeze dried powder) is 4.0 – 9.0 units/mg protein. The purity is ? 90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 units of functionally active C1 esterase inhibitor, pH 6.6 - 7.4, and an osmolality between 200 – 400 mosmol/kg. One unit (U) of CINRYZE (c1 esterase inhibitor human freeze dried powder) corresponds to the mean quantity of C1 esterase inhibitor present in 1 ml of normal fresh plasma.

VIDEX® is a brand name for didanosine, USP, a synthetic purine nucleoside analogue active against HIV-1.