NUCYNTA ER

NUCYNTA ER

  • 10/28/2011
  • Janssen Pharmaceuticals, Inc.
  • Tapentadol 50mg, 100mg, 150mg, 200mg, 250mg; ext-rel tabs.
  • Moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Not for as-needed use.
LAZANDA

LAZANDA

  • 10/21/2011
  • Archimedes Pharma
  • Fentanyl 100mcg, 400mcg; per 100mcL nasal spray.
  • Breakthrough pain, in opioid-tolerant patients already receiving and who are tolerant to continuous opioid therapy for underlying persistent cancer pain. Opioid-tolerant patients are those taking oral morphine ≥60mg/day, transdermal fentanyl ≥25mcg/hr, oral oxycodone ≥30mg/day, oral hydromorphone ≥8mg/day, oral oxymorphone ≥25mg/day, or equianalgesic dose of another opioid for ≥1 week.
GRALISE

GRALISE

  • 9/29/2011
  • Depomed, Inc.
  • Gabapentin 300mg, 600mg; tabs.
  • Postherpetic neuralgia.
SPRIX

SPRIX

  • 6/2/2011
  • Regency Therapeutics
  • Ketorolac tromethamine 15.75mg; per 100microliter nasal spray; contains EDTA.
  • For the short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.
ABSTRAL

ABSTRAL

  • 3/3/2011
  • ProStrakan Inc.
  • Fentanyl 100mcg, 200mcg, 300mcg, 400mcg, 600mcg, 800mcg; sublingual tablets.
  • Breakthrough pain, in opioid-tolerant patients already receiving and who are tolerant to continuous opioid therapy for underlying persistent cancer pain. Opioid-tolerant patients are those taking: Oral morphine ≥60mg/day, oxycodone ≥30mg/day, hydromorphone ≥8mg/day, oxymorphone ≥25mg/day, or equianalgesic dose of another opioid for ≥1 week; or transdermal fentanyl ≥25mcg/hr.
BUTRANS

BUTRANS

  • 1/6/2011
  • Purdue Pharma L.P.
  • Buprenorphine 5mcg/hour, 10mcg/hour, 20mcg/hour; transdermal patch.
  • Moderate to severe chronic pain when continuous opioid analgesia is needed for extended time period. Not for as-needed use.