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.
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.
Actavis on Monday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration to market buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets.
Actavis on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for a generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride extended-release tablets 8 mg, 12 mg and 16 mg).
A Pfizer painkiller appears to produce a much less positive experience for recreational drug users when crushed than when administered whole, according to results of a post-marketing clinical study program.