| Vanda Pharmaceuticals Inc. |
43068030406 |
Hetlioz LQ 158 mL 4mg/ mL |
2021-03-08 |
21205.5900 |
None |
1 |
15000 |
None |
1 |
None |
None |
None |
None |
SMS is estimated to affect 1/15,000-25,000 births in the U.S. (https://www.orpha.net/consor/cgi-bin/OC_Exp.php?Lng=GB&Expert=819) |
None |
| Vanda Pharmaceuticals Inc. |
43068030402 |
Hetlioz LQ 48 mL 4mg/ mL |
2021-03-08 |
6442.2000 |
None |
1 |
15000 |
None |
1 |
None |
None |
None |
None |
SMS is estimated to affect 1/15,000-25,000 births in the U.S. (https://www.orpha.net/consor/cgi-bin/OC_Exp.php?Lng=GB&Expert=819) |
None |
| Vgyaan Pharmaceuticals LLC |
72664061128 |
LEUPROLIDE ACETATE, 1MG/0.2ML, 2.8ML Vial |
2021-12-01 |
712.8000 |
None |
1 |
100000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| ViiV Healthcare |
49702025315 |
CABENUVA (cabotegravir 400 mg/2mL; rilpivirine 600 mg/2mL) |
2021-02-01 |
3960.0000 |
None |
1 |
609000 |
None |
1 |
None |
None |
None |
None |
Regarding Marketing/Pricing Plan Description, ViiV has not released CABENUVA'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 609,000 patient figure does not reflect the number of patients that are estimated to be treated with Cabenuva; rather, it represents the estimated number of virologically- suppressed adults (18+) in the US living with diagnosed HIV-1 infection, based on the CDC Selected National HIV Prevention and Care Outcomes, July 2019. To be eligible for Cabenuva according to the indication, in addition to being virologically suppressed, the patient must be on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to cabotegravir or rilpivirine, however since there are no known estimates for these parameters, the estimated number of patients provided does not reflect any assumptions regarding these clinical requirements, nor does it take into consideration a projection for the number of patients willing to switch to an injectable formulation. CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA consists of long-acting cabotegravir, an integrase strand transfer inhibitor (INSTI), and long-acting rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which allows for 2 separate once-monthly provider administered injections. This is the first FDA-approved long-acting complete regimen for HIV-infected adults administered by providers once a month.
CABENUVA was granted priority review by the Food And Drug Administration.
Note on Acquisition Fields: CABENUVA 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 |
49702024015 |
CABENUVA (cabotegravir 600 mg/3mL; rilpivirine 900 mg/3mL) |
2021-02-01 |
5940.0000 |
None |
1 |
609000 |
None |
1 |
None |
None |
None |
None |
Regarding Marketing/Pricing Plan Description, ViiV has not released CABENUVA'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 609,000 patient figure does not reflect the number of patients that are estimated to be treated with Cabenuva; rather, it represents the estimated number of virologically- suppressed adults (18+) in the US living with diagnosed HIV-1 infection, based on the CDC Selected National HIV Prevention and Care Outcomes, July 2019. To be eligible for Cabenuva according to the indication, in addition to being virologically suppressed, the patient must be on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to cabotegravir or rilpivirine, however since there are no known estimates for these parameters, the estimated number of patients provided does not reflect any assumptions regarding these clinical requirements, nor does it take into consideration a projection for the number of patients willing to switch to an injectable formulation. CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA consists of long-acting cabotegravir, an integrase strand transfer inhibitor (INSTI), and long-acting rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which allows for 2 separate once-monthly provider administered injections. This is the first FDA-approved long-acting complete regimen for HIV-infected adults administered by providers once a month.
CABENUVA was granted priority review by the Food And Drug Administration.
Note on Acquisition Fields: CABENUVA 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 |
| VistaPharm Inc |
66689011010 |
Lacosamide Oral Solution 20mL x 10 UDC |
2021-11-15 |
740.0000 |
None |
1 |
18000 |
None |
None |
None |
None |
None |
None |
This drug was not acquired from the approval owner. UCB is still the owner of the approval. |
None |