Akorn, Inc. (NASDAQ: AKRX) a niche generic pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of Dilaudid-HP® 10mg/ml Injection. The company intends to begin shipping the product next month.
In addition, the Company has commenced the manufacturing of Vancomycin HCL for Injection 5gm / vial in its Decatur, IL plant on a contract basis for sale through its joint venture subsidiary, Akorn-Strides. The additional manufacturing site allows the Akorn-Strides joint venture to increase production to meet its current demand for this product.
Raj Rai, the Interim Chief Executive Officer of Akorn stated, “These opportunities represent important milestones for our Company and are integral to the execution of our strategy to deliver high value pharmaceuticals.”
According to IMS Health, the U.S. sales for Hydromorphone Hydrochloride Injection 10mg/ml in 1ml, 5ml, and 50ml doses were approximately $28 million in 2009.
Related posts:
- Sun Pharma Announces USFDA Approval For Generic Flomax(R)
- Pharmacyclics Announces Multiple Presentations At The American Association For Cancer Research Annual Meeting
- Upsher-Smith Laboratories Announces Initiation Of Phase III Clinical Trial Of USL255 (Extended-Release Topiramate)
- Aeterna Zentaris Announces Initiation Of Phase 3 Registration Trial With Perifosine In Refractory Advanced Colorectal Cancer
- New Drug Approval Process (Drugs and The Pharmaceutical Sciences; Vol 190)
Join hundreds of students and get all book resources for FREE! Subscribe to Pharmacy E-books via RSS or via E-mail
