July 2023 Generic Product News

Pharmacy TimesJuly 2023
Volume 89
Issue 7

This months generic product news includes Nitisinone capsules, Prednisolone tablets, Carboprost Tromethamine injections, and Methsuximide capsules.

Nitisinone Capsules, 20 mg
From: Analog Pharma

Compare to:Orfadin

The FDA has approved an abbreviated new drug application for 20-mg nitisinone. Nitisinone capsules are a room temperature–stable, AB-rated treatment indicated for adult and pediatric patients with hereditary tyrosinemia type 1 who have a dietary restricted of tyrosine and phenylalanine. The most common adverse events from taking nitisinone include elevated tyrosine levels, low platelet count, low white blood cell count, eye conditions (pinkeye, white or cloudy cornea from scarring, corneal inflammation, light sensitivity, eye pain, inflammation of the eyelid, cataracts), and skin irritations.

FOR MORE INFORMATION: analogpharma.com

Medical balancing act. A group of medicine pills and antibiotics balancing on top of each other. 3D render illustration | Image credit: James Thew- stock.adobe.com

A group of medicine pills | Image credit: James Thew- stock.adobe.com

Prednisolone Tablets, 5 mg

From: Aurobindo

Compare to: Millipred

The FDA recently approved an abbreviated new drug application for prednisolone 5-mg oral tablets for a wide range of indications, including endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, gastrointestinal diseases, nervous system disorders, certain cases of tuberculous meningitis, and trichinosis with neurologic or myocardial involvement. The dosage can range from 5 mg to 60 mg daily and can be adjusted over time. The most common adverse events are mild and include weight gain, hair loss, nausea, increased appetite, fluid retention, and mild allergic reaction.


Carboprost Tromethamine Injection USP 250 μg/mL, single-dose vials

From: Eugia Pharma

Compare to: Hemabate Injection, 250 μg/mL

The FDA approved an abbreviated new drug application for Eugia Pharma to manufacture and market carboprost tromethamine injection, USP 250-μg/mL, single-dose vials. The injection is used to abort pregnancy between weeks 13 and 20 of gestation for specific indications, and it is also indicated to treat postpartum hemorrhage caused by uterine atony. Carboprost single-dose vials are expected to be available in Summer 2023.


Methsuximide Capsules, USP 300 mg

From: ANI Pharmaceuticals

Compare to: Celontin Capsules

The FDA approved an abbreviated new drug application for methsuximide capsules, USP 300 mg, according to an announcement from ANI Pharmaceuticals. They are indicated for the control of absence (petit mal) seizures that do not respond to other treatment. Methsuximide capsules also were given 180-day competitive generic therapy exclusivity because of inadequate generic competition. Methsuximide capsules are part of a $6.3 million market, according to IQVIA data.

FOR MORE INFORMATION: anipharmaceuticals.com

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