Boca Pharmacal Receives FDA Approval for Generic Version of Panlor(R)SS.Signs Exclusive Marketing and Distribution Agreement with Tedor Pharma for Generic Version of Didrex[R] CORAL SPRINGS Coral Springs, city (1990 pop. 79,443), Broward co., SE Fla.; inc. 1963. Largely residential, it is a city that has grown rapidly along with the southern Florida and Fort Lauderdale area. The population of Coral Springs nearly doubled between 1980 and 1990. , Fla. -- Boca Pharmacal, Inc. made two major announcements today with the U.S. Food and Drug Administration granting its final approval for the Company's Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) to market its generic version of and Panlor[R]SS (Acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. , Caffeine and Dihydrocodeine) and the signing of an exclusive marketing and distribution agreement with Tedor Pharma Inc. for Didrex[R] (Benzphetamine Hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid. hy·dro·chlo·ride n. A compound resulting from the reaction of hydrochloric acid with an organic base. ). Boca Pharmacal also announced that the company plans to launch both products immediately. Exclusive Marketing Agreement with Tedor to Market Generic Version of Didrex[R] The agreement with Tedor Pharma provides Boca Pharmacal with exclusive marketing and distribution rights for the generic version of Didrex[R] (Benzphetamine Hydrochloride) in 50mg tablet formats for oral administration. Benzphetamine Hydrochloride is used to decrease appetite in overweight and obese patients. "Boca Pharmacal and Tedor Pharma share the same corporate vision of offering top quality products manufactured and marketed in accordance with FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. regulations in a professional manner," said Theodore Iorio, President of Tedor Pharma. FDA Approval for Generic Version of Panlor[R]SS Boca Pharmacal also received final ANDA approval to market the generic version of Panlor[R]SS, Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate di·hy·dro·co·deine bitartrate n. A narcotic analgesic derived from codeine, about one-sixth as potent as morphine. in tablet form for oral administration to treat moderate to severe pain. Each tablet contains the following: Acetaminophen 712.8 mg, Caffeine 60 mg and Dihydrocodeine, 32 mg. "We are very pleased to extend our longstanding relationship with Tedor Pharma with this exclusive marketing and distribution agreement," said Robert J Edwards Jr., Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Boca Pharmacal. "Our latest approval represents another significant advancement for our company by increasing our generic product offerings and value priced alternatives for consumers. In addition to the approval of generic Panlor[R]SS, we expect five more approvals as well as filing 14 ANDA submissions during 2007." Boca Pharmacal's mission is to focus on delivering specialty type products that may have been overlooked by some of the larger generic companies. Both Acetaminophen, Caffeine and Dihydrocodeine (generic version of Panlor[R]SS) and Benzphetamine Hydrochloride (generic version of Didrex[R]) meet our criteria of offering lower volume but important drugs to patients in need. Founded in 1998 Coral Springs, FL-based Boca Pharmacal manufactures, develops and distributes a wide variety of generic drugs. For more information please visit http://www.bocapharmacal.com. |
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