| Validus Pharmaceuticals |
30698045502 |
Trazodone Hydrochloride Oral Solution, 10mg/mL Raldesy TM 150ml HDPE Bottle Pack |
2025-03-17 |
386.0000 |
None |
1 |
3897 |
None |
None |
None |
None |
None |
None |
Raldesy is the only oral liquid formulation of trazodone hydrochloride |
None |
| Validus Pharmaceuticals |
30698045501 |
Trazodone Hydrochloride Oral Solution, 10mg/mL Raldesy TM 300ml HDPE Bottle Pack |
2025-03-17 |
486.0000 |
None |
1 |
5846 |
None |
None |
None |
None |
None |
None |
Raldesy is the only oral liquid formulation of trazodone hydrochloride |
None |
| Verrica Pharmaceuticals Inc. |
71349007011 |
YCANTH 0.7% (w/v) 1 applicator |
2025-01-21 |
685.0000 |
None |
1 |
40000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Vertex Pharmaceuticals Incorporated |
51167012101 |
ALYFTREK (vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg film-coated tablets) is supplied as a 56-count tablet carton (4 wallets, each wallet containing 14 tablets of vanzacaftor/tezacaftor/deutivacaftor). |
2025-01-13 |
28404.2200 |
Marketing Plan Description:
Vertex’s commercial field team in the United States is composed of a small number of individuals, and we focus our United States marketing activities for ALYFTREK™ towards a limited number of physicians and health care professionals who are located at Cystic Fibrosis (CF)-focused accredited centers (CF care centers) in the United States.
The objective of these activities is to raise awareness and understanding about the approved indication, dosing, efficacy and safety data that are consistent with ALYFTREK’s FDA approved label.
Specific activities related to physicians and health care professionals include print distribution by the commercial field team to CF care centers, digital advertising (e.g., ALYFTREK’s product website), and other educational programs.
Specific activities related to people living with CF and their caregivers include print distribution of patient materials to CF care centers and digital advertising (e.g., ALYFTREK’s product website and social media pages). Vertex does not engage in traditional direct-to-consumer advertising (e.g., television or mass media). While not part of Vertex’s marketing plan, Vertex also operates a comprehensive patient support program, known as Vertex Guidance & Patient Support (Vertex GPS™), which helps eligible patients who have been prescribed ALYTREK (vanzacaftor, tezacaftor, and deutivacaftor) access their medication and help them stay on track with treatment.
Pricing Plan Description:
Vertex is relentless in our pursuit of medical research to discover medicines that can prevent, cure or fundamentally change the outcomes of serious disease for patients and their families. Our pricing philosophy supports this mission and reflects the transformative clinical value of our medicines, our commitment to patient access and the investment required to bring new medicines to other serious diseases.
When determining our price, we consider a combination of factors, including clinical value and the benefit to patients, patient access, economic value and impact to healthcare systems, investment required for the ongoing discovery and development of new medicines for CF and other serious diseases with few or no treatment options.
ALYFTREK™ (vanzacaftor/tezacaftor/deutivacaftor) is a clinical advancement in the treatment of CF patients. It is a once-daily, next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, that was studied in the most comprehensive Phase 3 pivotal program ever conducted in CF, including more than 1,000 patients, across more than 20 countries and more than 200 sites. Specifically, two randomized controlled trials (RCTs) versus TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor) in patients 12 years and older and a single-arm, open-label trial in patients 6-11 years of age. |
None |
28700 |
None |
1 |
None |
None |
None |
None |
Vertex estimates there are approximately 28,700 cystic fibrosis (CF) patients in the US with CF, ages 6 and older, who are eligible for ALYFTREK™ based on CF Registry data for 2024. Patients who are eligible for ALYFTREK have at least one F508del mutation, or another responsive mutation in the CFTR gene, and may also be eligible for other cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. |
None |
| Vertex Pharmaceuticals Incorporated |
51167013501 |
ALYFTREK (vanzacaftor 4 mg/tezacaftor 20 mg/deutivacaftor 50 mg film-coated tablets) is supplied as a 84-count tablet carton (4 wallets, each wallet containing 21 tablets of vanzacaftor/tezacaftor/deutivacaftor) |
2025-01-15 |
28404.2200 |
Marketing Plan Description:
Vertex’s commercial field team in the United States is composed of a small number of individuals, and we focus our United States marketing activities for ALYFTREK™ towards a limited number of physicians and health care professionals who are located at Cystic Fibrosis (CF)-focused accredited centers (CF care centers) in the United States.
The objective of these activities is to raise awareness and understanding about the approved indication, dosing, efficacy and safety data that are consistent with ALYFTREK’s FDA approved label.
Specific activities related to physicians and health care professionals include print distribution by the commercial field team to CF care centers, digital advertising (e.g., ALYFTREK’s product website), and other educational programs.
Specific activities related to people living with CF and their caregivers include print distribution of patient materials to CF care centers and digital advertising (e.g., ALYFTREK’s product website and social media pages). Vertex does not engage in traditional direct-to-consumer advertising (e.g., television or mass media). While not part of Vertex’s marketing plan, Vertex also operates a comprehensive patient support program, known as Vertex Guidance & Patient Support (Vertex GPS™), which helps eligible patients who have been prescribed ALYTREK (vanzacaftor, tezacaftor, and deutivacaftor) access their medication and help them stay on track with treatment.
Pricing Plan Description:
Vertex is relentless in our pursuit of medical research to discover medicines that can prevent, cure or fundamentally change the outcomes of serious disease for patients and their families. Our pricing philosophy supports this mission and reflects the transformative clinical value of our medicines, our commitment to patient access and the investment required to bring new medicines to other serious diseases.
When determining our price, we consider a combination of factors, including clinical value and the benefit to patients, patient access, economic value and impact to healthcare systems, investment required for the ongoing discovery and development of new medicines for CF and other serious diseases with few or no treatment options.
ALYFTREK™ (vanzacaftor/tezacaftor/deutivacaftor) is a clinical advancement in the treatment of CF patients. It is a once-daily, next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, that was studied in the most comprehensive Phase 3 pivotal program ever conducted in CF, including more than 1,000 patients, across more than 20 countries and more than 200 sites. Specifically, two randomized controlled trials (RCTs) versus TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor) in patients 12 years and older and a single-arm, open-label trial in patients 6-11 years of age. |
None |
28700 |
None |
1 |
None |
None |
None |
None |
Vertex estimates there are approximately 28,700 cystic fibrosis (CF) patients in the US with CF, ages 6 and older, who are eligible for ALYFTREK™ based on CF Registry data for 2024. Patients who are eligible for ALYFTREK have at least one F508del mutation, or another responsive mutation in the CFTR gene, and may also be eligible for other cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies. |
None |