| ChemoCentryx, Inc. |
73556016801 |
TAVNEOS (avacopan) 10 mg capsules, 1 x 180 |
2021-10-18 |
14450.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat adults diagnosed with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)), in line with the TAVNEOS?? Prescribing Information. Promotional activities to HCPs include sales representative detailing with appropriate supporting materials, journal ads, speaker programs, congress participation and non-personal promotion such as an HCP website, www.tavneos.com, search, banner advertising, and other digital educational programming. There is no sample program and no free trial offers for consumers.
Direct-to-consumer activities may include a patient website (with accompanying digital promotion), patient brochures, and additional resources such as a peer program or welcome kit. The purpose of the website, drivers to website, and brochure is to educate patients on the availability of new treatment options aligned to the TAVNEOS Prescribing Information and Medication Guide, including Important Safety Information. There is no direct-to-consumer marketing for TAVNEOS via TV.
ChemoCentryx considers multiple factors when setting a list price for a medicine, such as the following: 1. Value of the drug to patients; 2. The clinical and economic value of the drug; 3. Overall research and development costs; 4. Commitment to R&D and Innovation; 5. Cost of comprehensive patient support programs to ensure patient access. |
None |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| ChemoCentryx, Inc. |
73556016802 |
TAVNEOS (avacopan) 10 mg capsules, 1 x 30 |
2021-10-18 |
2408.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat adults diagnosed with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)), in line with the TAVNEOS?? Prescribing Information. Promotional activities to HCPs include sales representative detailing with appropriate supporting materials, journal ads, speaker programs, congress participation and non-personal promotion such as an HCP website, www.tavneos.com, search, banner advertising, and other digital educational programming. There is no sample program and no free trial offers for consumers.
Direct-to-consumer activities may include a patient website (with accompanying digital promotion), patient brochures, and additional resources such as a peer program or welcome kit. The purpose of the website, drivers to website, and brochure is to educate patients on the availability of new treatment options aligned to the TAVNEOS Prescribing Information and Medication Guide, including Important Safety Information. There is no direct-to-consumer marketing for TAVNEOS via TV.
ChemoCentryx considers multiple factors when setting a list price for a medicine, such as the following: 1. Value of the drug to patients; 2. The clinical and economic value of the drug; 3. Overall research and development costs; 4. Commitment to R&D and Innovation; 5. Cost of comprehensive patient support programs to ensure patient access. |
None |
1000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Chiesi USA |
10122021256 |
Bronchitol 4-Week Carton (56ct carton) |
2021-03-03 |
3482.0000 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with cystic fibrosis, materials to be used by sales representatives to share information on Bronchitol with HCPs who treat patients with cystic fibrosis or prescribe Bronchitol to such patients, and materials to educate patients about cystic fibrosis and Bronchitol. Sustainability has always been important for Chiesi, but today it is part of our strategic plan. This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work. |
None |
622 |
None |
None |
None |
None |
None |
None |
Acquired while in development; Approved while owned by Chiesi USA. |
None |
| Chiesi USA |
10122021214 |
Bronchitol 7-Day Carton (14ct carton) |
2021-03-03 |
870.5000 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with cystic fibrosis, materials to be used by sales representatives to share information on Bronchitol with HCPs who treat patients with cystic fibrosis or prescribe Bronchitol to such patients, and materials to educate patients about cystic fibrosis and Bronchitol. Sustainability has always been important for Chiesi, but today it is part of our strategic plan. This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work. |
None |
622 |
None |
None |
None |
None |
None |
None |
Acquired while in development; Approved while owned by Chiesi USA. |
None |
| Chiesi USA |
10122010305 |
FERRIPROX 1000mg (TID) FILM COATED TABLETS |
2021-09-25 |
7215.7300 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with thalassemia, sickle cell disease, and other anemias. Sustainability has always been important for Chiesi, but today it is part of our strategic plan. This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work. |
None |
650 |
None |
None |
None |
None |
None |
None |
New NDC reflecting manufacturer's labeler code. |
None |
| Chiesi USA |
10122010010 |
FERRIPROX 500mg FILM COATED TABLETS |
2021-11-01 |
7215.7300 |
Marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by Healthcare Providers (HCPs) most likely to manage patients with thalassemia, sickle cell disease, and other anemias. Sustainability has always been important for Chiesi, but today it is part of our strategic plan. This means that we are committed to improving the quality of life of patients, to protect the planet and its inhabitants, to put ourselves at the service of the community, to encourage the growth of our people, and to guarantee the maximum transparency of our work. |
None |
730 |
None |
None |
None |
None |
None |
None |
New NDC reflecting manufacturer's labeler code. |
None |
| Cintex Services LLC |
24470092360 |
Chlorzoxazone Tablets USP 250 mg |
2021-09-23 |
1194.0000 |
None |
1 |
12000 |
None |
None |
None |
None |
None |
None |
ANDA 215158 for this product was approved on 07/29/21. The approval owner was Senores Pharma. Cintex subsequently obtained marketing rights from Senores for this product, which will be sold under the Cintex label, NDC number 24470-0923-60. The begin marketing date/entry to marker for this NDC is 09/23/21. |
None |
| Civica, Inc |
72572003510 |
Bivalirudin Trifluoroacetate IV 250 mg 10 pack |
2021-01-01 |
1094.7000 |
None |
1 |
427081 |
None |
None |
2020-12-21 |
None |
1 |
Civica is selling under a product supply agreement under the manufacturer. There was no licensing fee, or acquisition price, only a fee per unit purchased from the manufacturer |
None |
None |