Pain
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CLINICAL_TRIALS trial_result · 2016-12-23Clinical Trial Update: Acupuncture and Chiropractic Care for Chronic Pain in an Integrated Health Plan
A Kaiser Permanente clinical trial evaluating acupuncture and chiropractic care for chronic pain within an integrated health plan has comple…
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CLINICAL_TRIALS trial_result · 2016-12-21Clinical Trial Update: Buprenorphine vs. Opioid Dose Escalation Among Patients With Chronic Pain [Phase 4]
Phase 4 trial comparing buprenorphine with escalating opioid doses in adults with chronic pain was terminated, with results posted in 2016.
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FDA approval · 2016-12-16FDA Approved: DISKETS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for DISKETS (methadone hydrochloride) from Hikma Pharmaceuticals USA Inc., reflecting an approved su…
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FDA approval · 2016-12-16FDA Approved: MS CONTIN — Supplemental Application (Rhodes Pharmaceuticals L.P.)
The FDA approved a supplemental application for MS CONTIN (morphine sulfate) submitted by Rhodes Pharmaceuticals L.P. This action confirms t…
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FDA approval · 2016-12-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., finalizing the approval of a generi…
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FDA approval · 2016-12-16FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (SpecGx LLC)
FDA approved a Supplemental Application for a generic oxycodone and acetaminophen product from SpecGx LLC under an ANDA.
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FDA approval · 2016-12-16FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for a generic acetaminophen and codeine phosphate product (SpecGx LLC) under ANDA 040419, enabling m…
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FDA approval · 2016-12-16FDA Approved: NALBUPHINE HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)
The FDA approved a supplemental application for nalbuphine hydrochloride from Hospira, Inc., authorizing a change to the product’s approval.
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FDA approval · 2016-12-16FDA Approved: METHADOSE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for Methadose (methadone hydrochloride) filed by SpecGx LLC.
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FDA approval · 2016-12-16FDA Approved: BUTRANS — Supplemental Application (Purdue Pharma LP)
FDA approved a supplemental application for BUTRANS (buprenorphine) from Purdue Pharma LP. This constitutes an additional regulatory action …
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FDA approval · 2016-12-16FDA Approved: OXAYDO — Supplemental Application (Zyla Life Sciences US LLC)
FDA approved a supplemental application for OXAYDO (oxycodone hydrochloride) from Zyla Life Sciences US LLC.
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FDA label_change · 2016-12-16FDA Approved: MORPHINE SULFATE — Supplemental Application (Hospira, Inc.)
The FDA approved a supplemental application for Morphine Sulfate by Hospira, Inc., resulting in changes to the drug's labeling.
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FDA approval · 2016-12-16FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (Aurolife Pharma, LLC)
FDA approved a supplemental application for Acetaminophen and Codeine Phosphate from Aurolife Pharma, LLC.
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FDA approval · 2016-12-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for methadone hydrochloride submitted by Mylan Institutional LLC. The action may involve labelin…
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FDA approval · 2016-12-16FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd)
FDA approved a supplemental application for buprenorphine hydrochloride from Advagen Pharma Ltd, representing an approved amendment to an ex…
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FDA approval · 2016-12-16FDA Approved: XTAMPZA ER — Supplemental Application (Collegium Pharmaceutical, Inc.)
The FDA approved a supplemental application for XTAMPZA ER (oxycodone) from Collegium Pharmaceutical, Inc., to modify the product labeling u…
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FDA approval · 2016-12-16FDA Approved: PENTAZOCINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for a pentazocine and naloxone combination product from Actavis Pharma, Inc.
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FDA approval · 2016-12-16FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for Acetaminophen and Codeine Phosphate manufactured by Strides Pharma Science Limited.
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FDA approval · 2016-12-16FDA Approved: BUTORPHANOL TARTRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for butorphanol tartrate filed by Hikma Pharmaceuticals USA Inc., updating the drug's labeling.
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FDA approval · 2016-12-16FDA Approved: BELBUCA — Supplemental Application (BioDelivery Sciences International Inc)
The FDA approved a supplemental application for Belbuca (buprenorphine hydrochloride) submitted by BioDelivery Sciences International Inc.
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FDA approval · 2016-12-16FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (Aurolife Pharma, LLC)
FDA approved a supplemental application for oxycodone and acetaminophen from Aurolife Pharma, supporting continued marketing of the generic …
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FDA approval · 2016-12-16FDA Approved: MORPHINE SULFATE — Supplemental Application (Fresenius Kabi, USA LLC)
FDA has approved a supplemental application for Morphine Sulfate submitted by Fresenius Kabi, USA LLC under NDA204223.
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CLINICAL_TRIALS trial_result · 2016-12-16Clinical Trial Update: Lavender Aromatherapy for Anxiety During Urodynamics [NA]
The completed trial evaluated lavender aromatherapy for reducing anxiety (and pain) during urodynamics, with results posted in December 2016…
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CLINICAL_TRIALS trial_result · 2016-12-16Clinical Trial Update: Intensive Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD) [NA]
Clinical trial update on an intensive treatment approach for chronic pain and post-traumatic stress disorder; the study has completed and re…
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FDA approval · 2016-12-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride by Hikma Pharmaceuticals USA Inc., granting regulatory clearance for…