FDA Approves Generic Dexamethasone Tablets USP

On August 16, 2022, the FDA approved generic dexamethasone tablets USP (ANI Pharmaceuticals, Inc. [ANI]) at 1.5 mg, 4 mg, and 6 mg dosages following ANI’s submission of an abbreviated new drug application (ANDA) for the drug.¹

From the reference drug Decadron (Merck & Co, Inc), ANI developed the generic dexamethasone tablets USP as a generic alternative. According to IQVIA/IMS Health, dexamethasone tablets are valued at approximately $60 million on the US market, with ANI’s generic poised to take a share of the pot.¹

"The FDA approval and imminent launch of dexamethasone tablets further demonstrates our commitment to serve patients in need by bringing limited competition products to market,” said Nikhil Lalwani, president and chief executive officer of ANI, in a press release.²

Dexamethasone is a corticosteroidthat can treat inflammation, certain forms of arthritis, certain cancer types, severe allergies, and asthma.² Dexamethasone is similar to a hormone in that it is naturally produced in the adrenal glands; however, it is able to replace the hormone if not enough of it is being produced.³

Corticosteroids inhibit pro-inflammatory signals and promote anti-inflammatory signals, having a wide range of therapeutic activities.⁴ Dexamethasone is structurally similar to other corticosteroids which treat a range of endocrine, dermatological, and respiratory conditions.⁴

First granted FDA approval in 1958, dexamethasone has since been used to treat inflammatory conditions and others, notably being recommended for patients with severe respiratory COVID-19 symptoms in 2020.⁴ Dexamethasone reduced deaths by about 33% in patients requiring ventilation, and by 20% in individuals requiring oxygen.⁴

“[We serve] patients in need, especially those suffering from diseases for which there is a significant unmet medical need,” Lalwani said in the press release. “Generics business fortification, existing brand innovation, and utilizing North American manufacturing capabilities are all priorities for our team as we work to create sustainable growth.”⁵

References

1. ANI Pharmaceuticals Inc. ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Dexamethasone Tablets USP. Business Wire. August 16, 2022. Accessed August 17, 2022. https://www.businesswire.com/news/home/20220816005393/en
2. ANI Pharmacetucials Inc. ANI Pharmaceuticals Receives FDA Approval for Dexamethasone Tablets. Dow Jones Newswires. August 16, 2022. Accessed on August 17, 2022. https://www.marketwatch.com/story/ani-pharmaceuticals-receives-fda-approval-for-dexamethasone-tablets-271660648060
3. Dexamethasone. MedlinePlus website. September, 2017. Accessed on August 17, 2022. https://medlineplus.gov/druginfo/meds/a682792.html
4. Dexamethasone. DrugBank Online. Accessed on August 17, 2022. https://go.drugbank.com/drugs/DB01234
5. Mendonca, Elaine. The Food and Drug Administration has approved Dexamethasone Tablets USP by ANI Pharma (ANIP). Best Stocks. August 16, 2022. Accessed on August 17, 2022. https://beststocks.com/the-food-and-drug-administration-has-approved-dexa/