| Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc |
23155054025 |
Doxercalciferol Capsules 2.5 mg 50 ct |
2021-02-24 |
695.0000 |
None |
1 |
250 |
None |
None |
None |
None |
None |
None |
None |
None |
| Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc |
23155074841 |
Pentamidine Isethionate for Injection 300mg 10 pack |
2021-05-25 |
977.0000 |
None |
1 |
3500 |
None |
None |
None |
None |
None |
None |
None |
None |
| Heritage Pharmacueticals Inc. D/B/A Avet Pharmacueticals Inc |
23155079041 |
Carmustine for Injection 100 mg i Vial Private Label |
2021-07-06 |
1226.0000 |
None |
1 |
700 |
None |
None |
2012-11-28 |
None |
1 |
None |
None |
None |
| Hikma Pharmaceuticals USA Inc |
00054048013 |
Everolimus Tablets 2.5mg, Bottle of 30 |
2021-02-10 |
12012.9800 |
None |
1 |
76080 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma is replacing previously launched NDC #00054-0480-14 (blister pack of 28 tablets) with a new package configuration of 30 tablets per bottle.
Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately76,080 people will be diagnosed with advanced renal cell carcinoma. |
None |
| Hikma Pharmaceuticals USA Inc |
00054363063 |
Naproxen Oral Suspension, USP, 125mg per 5mL, 500mL Bottle |
2021-02-22 |
896.4400 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
29000000 |
None |
None |
2015-07-28 |
2650000000.0000 |
None |
The ANDA for Naproxen OS was acquired along with all of the assets of Roxane Laboratories, Inc. in a transaction which closed February 29, 2016. Total acquisition price was 2,650,000,000.00 including the Naproxen ANDA. |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available.
Hikma has not evaluated the volume of patients in the USA. Naproxen oral suspension is a non-steroidal anti-inflammatory drug indicated for the relief of the signs and symptoms of: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendonitis, bursitis, acute gout; and the management of: pain and primary dysmenorrhea. According to sciencedaily.com, about 29 million Americans use over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) to treat pain. |
None |
| Hikma Pharmaceuticals USA Inc |
00054057625 |
Deferiprone Tablets, 500mg, 1 bottle of 100 |
2021-05-29 |
6148.0800 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
1000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Deferiprone is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. According to the Boston Children's Hospital, in the United States, there are only about 1,000 people with thalassemia major |
None |
| Hikma Pharmaceuticals USA Inc |
00054042623 |
Rufinamide Tablets, 400mg, 1 bottle of 120 |
2021-05-30 |
737.0400 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
86060 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Rufinamide is indicated as adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome ("LGS") in pediatric patients 1 year of age and older and in adults. The incidence of LGS is estimated at approximately 26 per 100,000 people. Therefore, there are approximately 86,060 patients in the United States. |
None |
| Hikma Pharmaceuticals USA Inc |
00054048113 |
Everolimus Tablets, 5mg, bottle of 30 |
2021-06-07 |
12565.3700 |
This is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
76080 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma is replacing previously launched NDC #00054-0481-14 (blister pack of 28 tablets) with a new package configuration of 30 tablets per bottle.
Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately 76,080 people will be diagnosed with advanced renal cell carcinoma. |
None |
| Hikma Pharmaceuticals USA Inc |
00143929910 |
Ganciclovir for Injection, 500mg, 20mL |
2021-06-14 |
684.0000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
10000000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma has not evaluated the volume of patients in the USA. Ganciclovir is indicated for the treament of CMV retinitis in immunocompromised adult patients; or prevention of CMV disease in adult transplant recipients. According to the Medline Plus, approximately 50% and 80% of adults in the US have had a CMV infection by age 40. |
None |
| Hikma Pharmaceuticals USA Inc |
00143939810 |
Ertapenem for Injection, 1GM, vial size 20mL, 10 vial package |
2021-08-16 |
900.0000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
13100 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Ertapenem Injection is a penem antibacterial indicated for the treatment of moderate to severe infections caused by susceptible bacteria. According to the CDC.gov, in 2017 CRE ("carbapenem-resistant Enterobacterales") caused an estimated 13,100 infections in the United States. |
None |
| Hikma Pharmaceuticals USA Inc |
00054049713 |
Everolimus Tablets, 7.5mg, bottle of 30 |
2021-08-23 |
12565.3700 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
76080 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product. Hikma is replacing previously launched NDC #00054-0497-14 (blister pack of 28 tablets) with a new package configuration of 30 tablets per bottle.
Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately 76,080 people will be diagnosed with advanced renal cell carcinoma. |
None |
| Hikma Pharmaceuticals USA Inc |
00054060421 |
Everolimus Tablets, 1mg, Bottle of 60 |
2021-11-19 |
1902.8500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
106859 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: kidney and liver transplant. According to organdonor.gov, there are approximately 106,859 people on the national transplant waiting list. |
None |
| Hikma Pharmaceuticals USA Inc |
00054048213 |
Everolimus Tablets, 10mg, Bottle of 30 |
2021-11-23 |
6714.6200 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
70080 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Everolimus is a kinase inhibitor indicated for the treatment of (1) advanced renal cell carcinoma; and (2) renal angiomyolipoma and tuberous sclerosis complex. According to the American Cancer Society, in 2021 approximately 76,080 people will be diagnosed with advanced renal cell carcinoma. |
None |