| Validus Pharmaceuticals |
30698022010 |
Anzemet 50mg tablets 10 count |
2022-05-24 |
295.6200 |
None |
1 |
1000000 |
None |
None |
2015-12-21 |
None |
1 |
The NDA # 20-623 was part of a portfolio purchased from Sanofi Aventis in 2015. |
Anzemet Tablets NDA #20-623 was approved by the FDA on 09/11/1997
NDC # 30698-0220-10 is a relaunch under a new packing size
There is a price decrease per pill. The prior WAC price was $72.05 per pill. The new WAC price is $29.56 under NDC # 30698-0220-10
Anzemet Tablets is a antiemetic used primarily (but not exclusively) by patients
receiving chemotherapy. This is only one of several options for antiemetics. |
None |
| Vifor (International) Inc. |
59353006512 |
KORSUVA (difelikefalin) injection Carton containing 12 single-dose vials |
2022-05-02 |
1800.0000 |
Vifor (International) Inc. plans to market Korsuva to appropriate healthcare professionals who treat moderate to severe CKD-aP adult patients on hemodialysis. Currently, Vifor does not plan to engage in television or radio advertising or promotional campaigns. The current WAC is set at $150.00 per single-dose vial, and at $1,800.00 for a standard 30-day supply. The list price of Korsuva is not reflective of discounts and rebates which may be available to various government and private payers and purchasers. |
None |
33000 |
1 |
1 |
None |
None |
None |
None |
Vifor did not acquire Korsuva and has therefore left acquisition-related data fields blank. |
None |
| Vifor (International) Inc. |
59353006501 |
KORSUVA (difelikefalin) injection 65 mcg/1.3 mL single-dose vial |
2022-05-02 |
150.0000 |
Vifor (International) Inc. plans to market Korsuva to appropriate healthcare professionals who treat moderate to severe CKD-aP adult patients on hemodialysis. Currently, Vifor does not plan to engage in television or radio advertising or promotional campaigns. The current WAC is set at $150.00 per single-dose vial, and at $1,800.00 for a standard 30-day supply. The list price of Korsuva is not reflective of discounts and rebates which may be available to various government and private payers and purchasers. |
None |
33000 |
1 |
1 |
None |
None |
None |
None |
The data entered in the “WAC at Intro to Market” data field is based on the WAC for a single therapeutic dose, however a normal course of therapy would have a monthly WAC price of 1800, therefore necessitating reporting. |
None |
| ViiV Healthcare |
49702026423 |
APRETUDE (cabotegravir 600mg/3 mL) |
2022-01-24 |
3700.0000 |
None |
1 |
1200000 |
1 |
1 |
None |
None |
None |
None |
Regarding Marketing/Pricing Plan Description, ViiV has not released APRETUDE's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
The 1,200,000 patient number does not reflect the number of persons that are estimated to be prescribed Apretude; it represents the estimated number of persons in the US that had indications for PrEP (Pre-exposure Prophylaxis) in 2019. According to the CDC, an estimated 1.2 million persons in the US had indications for PrEP and approximately 284,000 were prescribed PrEP in 2019. The 2019 approximations for California were about 165,000 persons with PrEP indications and 44,000 persons prescribed PrEP. The 2019 US and California estimates are based on Centers for Disease Control and Prevention. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data—United States and 6 dependent areas, 2019. HIV Surveillance Supplemental Report 2021;26(No. 2), published May 2021. Apretude is indicated in at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
APRETUDE was granted a priority review and breakthrough therapy designation by the Food And Drug Administration.
Note on Acquisition Fields: APRETUDE was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT. |
None |
| ViiV Healthcare |
49702025837 |
TRIUMEQ PD Tablets for Oral Suspension (abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg) |
2022-05-04 |
1001.7200 |
None |
1 |
1900 |
None |
1 |
None |
None |
None |
None |
Regarding Marketing/Pricing Plan Description, ViiV has not released TRIUMEQ PD's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c).
The 1,900 patient number does not reflect the number of persons that are estimated to be prescribed TRIUMEQ PD; it represents the estimated number of children aged less than 13 years living with diagnosed HIV infection, Year-end 2018 - United States and 6 Dependent Areas. This 2018 estimate is based on the Centers for Disease Control and Prevention, HIV Surveillance Report, 2018 Updated Edition, Volume 31: Diagnoses of HIV Infection in the United States and Dependent Areas, 2018: Children Aged < 13 years. Data for the year 2018 are preliminary and based on deaths reported to CDC as of December 2019. This estimate does not reflect new infections for 2019-2021. TRIUMEQ PD is indicated for the treatment of pediatric patients weighing 10 kgs to < 25 kgs with human immunodeficiency virus type 1 (HIV-1).
TRIUMEQ PD was granted priority review by the Food And Drug Administration.
Note on Acquisition Fields: TRIUMEQ PD was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT. |
None |