05.04.2016 14:13:33

ANI Pharma Announces FDA Approval Of Oxycodone Capsules, 5mg

(RTTNews) - ANI Pharmaceuticals Inc. (ANIP) announced that it has received approval from the U.S. Food and Drug Administration of the Abbreviated New Drug Application or "ANDA" for Oxycodone HCl Capsules, 5mg. Trailing twelve-month sales for the product are $7.5 million according to IMS Health.

Oxycodone hydrochloride is an opiod agonist indicated for the management of moderate to severe acute and chronic pain where the use of an opiod analgesic is appropriate.

In a separate press release, ANI Pharmaceuticals announced the commercial launch of 1% and 2.5% hydrocortisone cream for rectal use. The combined market for these products was $84 million over the trailing twelve months through February 2016, according to IMS Health.

Topical corticosteroids such as 1% and 2.5% hydrocortisone cream are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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