Teva Granted Approval for Fluoxetine Capsules
Posted on: Thursday, 22 May 2008, 09:01 CDT
Teva Pharmaceutical Industries has announced that the FDA has granted final approval for the company's abbreviated new drug application for Fluoxetine capsules USP, 10mg and 20mg.
As the first company to file an abbreviated new drug application containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Teva's Fluoxetine capsules are the AB-rated generic equivalent of Eli Lilly's Sarafem Pulvules, and are indicated for the treatment of premenstrual dysphoric disorder.
Source: Datamonitor
Related Articles
- Teva Comments on Market Rumors
- Teva Announces Tentative Approval of Fexofenadine HCl Tablets
- Teva Announces Tentative Approval of Tramadol and Acetaminophen Tablets
- Teva Announces Record Global In-Market Copaxone(R) Sales of $291 Million in the Second Quarter, an Increase of 29%
- Teva Comments on FDA Letter Regarding Pravastatin Exclusivity
- Teva and Active Biotech Announce the Submission of an IND to the FDA for Laquinimod, an Oral Product for the Treatment of Relapsing MS
- Teva and Lundbeck Announce European Approval for AZILECT -Rasagiline- 1mg for Parkinson's Disease
- Teva Announces That Azilect -Rasagiline- is Approved for Marketing in Israel
- Dow Up 34, Nasdaq Up 2 on Teva Merger
- Dow Up 28, Nasdaq Up 3 on Teva Merger
Rating: 2.6 / 5 (8 votes)
 |
 |
Rate this article:
User Comments (0)
RSS Feeds