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MedMonitor

An up-to-date timeline of FDA approvals that could impact workers' comp
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Kombiglyze® XR (saxagliptin and metformin hydrochloride) extended-release tablets

Approval Date: Jul 2023

Note: First-Time Generic

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate

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RiVive (naloxone hydrochloride) nasal spray

Approval Date: Jul 2023

Note: New Product

Indicated for the emergency treatment of known or suspected opioid overdose, this drug is the second over-the-counter nonprescription opioid overdose drug approved by the FDA

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Spiriva® HandiHaler (tiotropium bromide) inhalation powder

Approval Date: Jun 2023

Note: First-Time Generic

For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

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Katerzia® (amlodipine benzoate) oral suspension

Approval Date: Jun 2023

Note: First-Time Generic

For the treatment of hypertension and coronary artery disease

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Fleqsuvy (baclofen) oral suspension

Approval Date: Jun 2023

Note: First-Time Generic

Indicated for the treatment of spasticity resulting from multiple sclerosis, as well as in patients with spinal cord injuries or diseases.

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Diastat® AcuDial (diazepam) rectal gel delivery system

Approval Date: May 2023

Note: First-Time Generic

Indicated for the management of selected, refractory, patients with epilepsy, on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity

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Celontin® (methsuximide) capsules

Approval Date: May 2023

Note: First-Time Generic

Indicated for the control of absence (petit mal) seizures that are refractory to other drugs

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Yuflyma (adalimumab-aaty) injection

Approval Date: May 2023

Note: New Product

A biosimilar to Humira (adalimumab) this drug is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, and plaque psoriasis

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Paxlovid (nirmatrelvir and ritonavir) tablets

Approval Date: May 2023

Note: New Product

Indicated for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19

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Inpefa (sotagliflozin) tablets

Approval Date: May 2023

Note: New Product

Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes

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