capsules are the generic version of Tessalon from Pfizer and is used to treat coughs caused by the common cold and other breathing problems.
In the past, patients would receive 2 100-mg benzonatate perles, which they kept on the tongue until the perles dissolved.
Recommended maximum adult dose Anesthetic Dose Lidocaine 4% (40 mg/ml) 7 to 8 ml (or 4.5 mg/kg; ~300 mg for a 70-kg patient) Tetracaine 2% (20 mg/ml) 0.9 ml * Benzocaine/tetracaine spray 2-sec spray Benzonatate 200 mg * When tetracaine is administered via an atomizer for nasal anesthesia, only 0.1 to 0.2 ml is typically used.
That left Ascend to supply the entire market at a time when several dynamics conspired together to dramatically increase the demand for benzonatate. Those dynamics included a decision by the Food and Drug Administration to change the rules for physicians calling pharmacies for prescriptions for cough syrups.
This process has swayed many physicians to turn to benzonatate for cough control because of its nonnarcotic profile and ease of use.
"Benzonatate is a fairly difficult product to manufacture," said Bill Moran, Ascend's procurement director.
While the company's current line is small, consisting of ibuprofen, allopurinol, SSD 1% cream, oxcarbazepine and benzonatate
, it expects additional approvals shortly and has a strong development pipeline.
Fluconazole $65,766,867.18 Mylan Temazepam $65,618,660.60 Teva USA Amlodipine Besylate-Benazepril $64,483,720.47 Teva USA Carbidopa/Levodopa $64,345,110.47 Upsher-Smith Klor-Con m20 $64,291,615.95 Watson Labs Paroxetine HCl $64,245,885.82 Sandoz Metoprolol Succinate $63,979,669.73 Watson Labs Microgestin FE $63,821,408.45 Ranbaxy Cefuroxime $63,793,461.21 Sandoz Terazosin HCl $63,694,060.65 Inwood Labs Benzonatate
$63,656,382.85 Mylan Zolpidem Tartrate $62,894,343.85 Watson Labs Morphine Sulfate $62,365,730.86 Mylan Nitrofurantoin Monohyd Macro $61,359,840.55 Greenstone Ltd.
Recent approvals include paroxetine tablets, bioequivalent to GSK's Paxil; benzonatate
(100- and 200-mg) capsules, bioequivalent to Forest Laboratories Inc.'s Tessalon; and azathioprine tablets, bioequivalent to Prometheus Inc.'s Imuran.