Generic Product News: October 2023

Pharmacy TimesOctober 2023
Volume 89
Issue 10

The products include Indomethacin 50 mg suppositories, Fluocinolone Acetonide Oil 0.01%, GA Depot 40 mg, Saxagliptin Tablets, 2.5 mg and 5 mg

Indomethacin 50 mg suppositories

From: Zydus Lifesciences

Compare To: Indocin

Image credit: PHTM Retail - October 2023 Issue

Image credit: PHTM Retail - October 2023 Issue

Zydus Lifesciences received FDA approval for its indomethacin suppositories, 50 mg, accordingn to a company news release. The suppositories are a nonsteroidal anti-inflammatory treatment for moderate to severe rheumatoid arthritis; they are also indicated to treat others types of arthritis, including moderate to severe ankylosing spondylitis and osteoarthritis, and acute forms of painful shoulder (bursitis and/or tendinitis) or gouty arthritis.


Fluocinolone Acetonide Oil 0.01%

From: Novel Laboratories, Inc

Compare To: Derma-Smoothe/FS 0.01%

The FDA gave its final nod to an abbreviated new drug application for fluocinolone acetonide oil, a scalp oil manufactured by the Lupin Limited subsidiary Novel Laboratories, Inc. Fluocinolone acetonide oil is indicated for atopic dermatitis (eczema) and is like other topical corticosteroids because it is anti-inflammatory, antipruritic, and vasoconstrictive. This makes it effective for itchiness, dry skin, rashes, redness, scaly patches, blisters, and skin infections associated with eczema.


GA Depot 40 mg

From: Viatris Inc, Mapi Pharma Ltd

Compare To: Copaxone

The FDA will review a new drug application for GA Depot 40 mg, a long-acting glatiramer acetate for relapsing forms of multiple sclerosis (MS). In a phase 3 study, which randomly assigned 1016 patients to receive 40 mg of GA Depot or placebo via intramuscular injection once every 4 weeks, GA Depot 40 mg reduced rate of relapse by 30.1% compared with placebo (P = .0066). Approximately 1 million people in the United States have MS, according to data from the National Multiple Sclerosis Society, with an estimated 85% having a relapsed/remittent form of the disease.


Saxagliptin Tablets, 2.5 mg and 5 mg

From: Aurobindo

Compare To: Onglyza Tablets

Aurobindo’s abbreviated new drug application for saxagliptin tablets recently received FDA approval, according to an Aurobindo news release. Saxagliptin tablets—approved for strengths of 2.5 mg and 5 mg—are indicated as an adjunct treatment with diet and exercise to promote glycemic control in adult patients with type 2 diabetes mellitus. Diet and exercise are effective for blood sugar maintenance, and medications can further mitigate high blood sugar. The most common adverse events associated with saxagliptin tablets include upper respiratory tract infection, urinary tract infection, and headache.


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