Background
Pentalong® was developed in the USA in the 1950s. Since 1964 it was produced in the former GDR by a Zwickau company. Today the company Actavis holds the rights to Pentalong®.
However, since the drug never had to go through an approval procedure, Actavis had to apply for a subsequent approval. This was the procedure for all drugs that came onto the market before 1976, as their quality, efficacy and safety had to be verified. However, Actavis did not meet the requirements set by the Federal Institute for Drugs and Medical Devices, so that the approval of Pentalong® initially expired in 2005.
Actavis filed a complaint against this decision and subsequently submitted studies to prove the efficacy of Pentalong® 80mg. The studies were not convincing, so that the approval of this drug finally expired in 2014. A fictitious approval for the lower dosage of 50mg still exists, so that this drug remains marketable.
However, it is no longer reimbursed by the statutory health insurance. The patient must pay for it himself. For this reason, many patients have had to switch their medication from Pentalong® to other nitrate-containing drugs. Alternative active ingredients are, for example, isosorbide dinitrate (ISDN) and isosorbide mononitrate (ISMN), as well as nitrosprays if required, which also belong to the group of nitrates and thus have a vasodilating effect.
