Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

Skytrofa® (lonapegsomatropin-tcgd) – New orphan drug approval

Ascendis Pharma announced the FDA approval of Skytrofa (lonapegsomatropin-tcgd), for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). August 25, 2021

Briviact® (brivaracetam) – Expanded indication

UCB announced the FDA approval of Briviact (brivaracetam), for the treatment of partial-onset seizures in patients 1 month of age and older. August 30, 2021

Tecentriq® (atezolizumab) – Indication withdrawal

Roche announced the voluntary withdrawal of the Tecentriq (atezolizumab) indication for use in combination with paclitaxel protein-bound, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. August 27, 2021

Tibsovo® (ivosidenib) – New indication

Servier Pharmaceuticals announced the FDA approval of Tibsovo (ivosidenib), for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Invega Hafyera Approved

Janssen’s Invega Hafyera™ (paliperidone palmitate) extended-release injectable suspension received approval from the U.S. Food and Drug Administration (FDA) on. It is a new longer-acting version of the atypical antipsychotic that is administered by intramuscular (IM) injections twice each year by a healthcare provider to treat adults who have schizophrenia. August 30, 2021

Trudhesa – FDA Approves

A new brand of dihydroergotamine (DHE) mesylate was FDA approved on. Impel NeuroPharma’s Trudhesa™ nasal spray is indicated to treat adults who have acute migraine headaches whether or not they are accompanied by auras. Sept 2, 2021

Brukinsa – Second Indication Awarded

Brukinsa® (zanubrutinib – BeiGene) capsules was FDA approved on Aug. 31, 2021, to treat adults who have Waldenström’s macroglobulinemia (WM). A rare type of non-Hodgkin lymphoma, WM is most common among older adults.

Keytruda Indication Revised

Accelerated Approval is given by the FDA for drugs that show promise for treating serious or life-threatening diseases in clinical studies, even though the studies have not been completed.

Teligent Pharma Recall

Teligent Pharma recalled one lot of lidocaine topical solution, 4% in 50mL bottles. Testing of samples from the recalled lot found it to be much stronger than indicated on the label. Aug. 27, 2021

This information is shared with you from our partners at OptumRx.

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