Watson Pharmaceuticals, Inc. has announced that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for albuterol sulfate inhalation solution in the 0.021% (base) and 0.042% (base) strengths. Watson has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the 0.021% (base) strength. Watson's market exclusivity will begin upon commercial launch. Watson intends to launch its albuterol sulfate inhalation product immediately.
Watson Pharmaceuticals receives FDA approval for generic Accuneb
Watson Pharmaceuticals, Inc. has announced that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for albuterol sulfate inhalation solution in the 0.021% (base) and 0.042% (base) strengths. Watson has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the 0.021% (base) strength. Watson's market exclusivity will begin upon commercial launch. Watson intends to launch its albuterol sulfate inhalation product immediately.
Watson Pharmaceuticals receives FDA approval for generic Accuneb