November 2019 Generic Product News

Pharmacy Times, November 2019, Volume 85, Issue 11

This month's generic products include nitisinone capsules, sapropterin dihydrochloride oral powder, and more.

NITISINONE CAPSULES

MARKETED BY: Endo International

COMPARE TO: Orfadin capsules

The FDA recently approved nitisinone capsules as the first generic for Orfadin capsules used to treat hereditary tyrosinemia type 1 (HT-1). HT-1 is a metabolic disorder that occurs when the body does not produce enough of an enzyme that breaks down proteins from certain foods. Left untreated, it can cause hepatic, peripheral nerve, and renal damage. Endo’s operating company, Par Pharmaceutical, has started distributing the product through specialty pharmacies.

DOSAGE FORM: Capsules

FOR MORE INFORMATION: endo.com

POSACONAZOLE (ORAL/ INJECTION)

MARKETED BY: Sinotherapeutics Inc

COMPARE TO: Noxafil tablets

Posaconazole, Sinotherapeutics Inc’s generic version of Noxafil, has been approved by the FDA. The drug will be available in injection and oral forms and is used to prevent fungal infections in individuals with a weak immune system resulting from certain conditions or treatments. The posaconazole oral suspension is also used to treat oral thrush. Common adverse effects may include cough, diarrhea, fever, headache, low potassium, nausea, and vomiting.

DOSAGE FORM: Tablets

FOR MORE INFORMATION: sinotherapeutics.com

SAPROPTERIN DIHYDROCHLORIDE ORAL POWDER

MARKETED BY: Par Pharmaceutical

COMPARE TO: Kuvan Powder for Oral Solution

Par Pharmaceutical has received approval for its sapropterin dihydrochloride oral powder in 100- and 500-mg packets. Sapropterin

is used to lower blood levels of phenylalanine in people with a certain type of phenylketonuria, a disorder in which the body cannot break down phenylalanine. Elevated phenylalanine levels can cause problems with behavior and thinking.

DOSAGE FORM: Oral powder

FOR MORE INFORMATION: parpharm.com

TAFLUPROST OPHTHALMIC

MARKETED BY: Micro Labs Limited

COMPARE TO: Zioptan

Tafluprost Ophthalmic has been approved as a generic of Zioptan to treat open-angle glaucoma or other causes of increased pressure inside the eye. Tafluprost is a fluorinated prostaglandin F2-α analogue thought to reduce intraocular pressure by increasing outflow of aqueous humor via the uveoscleral pathway. Common adverse effects include headaches and irritation or stinging of the eye. Tafluprost Ophthalmic may also cause a gradual change in the color of the eyelids, eyes, or lashes, which may be permanent, even after treatment ends.

DOSAGE FORM: Eye drops

FOR MORE INFORMATION: microlabsltd.com