Purdue Pharma on Thursday announced that the Food and Drug Administration approved Hysingla ER (hydrocodone bitartrate) extended‐release tablets CII, a once‐daily, single‐entity medication formulated using Purdue’s proprietary extended‐release solid oral platform, Resistec.
Pfizer last week announced that the Food and Drug Administration approved a revised label for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules, for oral use, CII, to include abuse-deterrence studies.
Purdue Pharma has launched an awareness campaign to address specific knowledge gaps among pharmacists related to its Schedule III extended-release transdermal opioid, Butrans.
The Drug Enforcement Administration’s final rule moving hydrocodone combination products from Schedule III to the more-restrictive Schedule II officially went into effect on Monday.
Purdue Pharma on Thursday announced the launch of a new dosage strength of 7.5 mcg/hour for its Butrans (buprenorphine) transdermal system CIII, bringing the total number of strengths offered by the company to five.
Teva Pharmaceutical Industries on Wednesday announced the initiation of a rolling new drug application submission for hydrocodone bitartrate extended-release tablets.
Salix Pharmaceuticals and Progenics Pharmaceuticals announced that the Food and Drug Administration approved Relistor (methylnaltrexone bromide) subcutaneous injection in 12-mg dosage strength to treat constipation in patients taking opioids for chronic, non-cancer pain.
The National Association of Chain Drug Stores submitted a statement urging transparency, collaboration and prioritization in working with pharmacy and other healthcare stakeholders to help protect patient access and fight prescription drug abuse and diversion.
The Food and Drug Administration on Tuesday announced approval for Movantik (naloxegol), a treatment for opioid-induced constipation in adults.