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Friday, August 19, 2022 12:58:16 PM
Any idea how long it takes to receive approval of a Prodrug?
Prodrug technology has been successfully utilized to develop therapeutics and treat patients for more than 100 years. Many of the world’s best known and most widely used pharmaceuticals are, in fact, prodrugs—with aspirin being the industry’s poster child. Approximately 7% of all drugs approved globally are prodrugs. Elegant in concept, prodrugs are inactive, bioreversible derivatives of active-drug molecules that must undergo an enzymatic or chemical transformation to release the parent drug, which can then elicit its desired pharmacological effect in the body.
Apadaz FDA Approval History
https://www.drugs.com/history/apadaz.html
FDA Approved: Yes (First approved February 23, 2018)
Brand name: Apadaz
Generic name: acetaminophen and benzhydrocodone hydrochloride
Dosage form: Tablets
Previous Name: KP201
Company: KemPharm, Inc.
Treatment for: Pain
Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an immediate release combination of acetaminophen and benzhydrocodone, a prodrug of the opioid agonist hydrocodone, indicated for the short-term management of acute pain.
Development timeline for Apadaz
Date Article
Jan 7, 2019 Approval KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)
Feb 23, 2018 Approval FDA Approves Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain
Jun 13, 2016 FDA Issues Complete Response Letter for Apadaz New Drug Application NDA
May 5, 2016 Statement Regarding FDA Advisory Committee Meeting on KemPharm’s Abuse-Deterrent Product Candidate Apadaz
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