Alembic gets USFDA nod for Tizanidine hydrochloride capsules used to treat spasticity
- Country:
- India
Drug firm Alembic Pharmaceuticals on Wednesday said it has received a final nod from the US health regulator for Tizanidine hydrochloride capsules, used to treat spasticity. "The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing.
Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important.
"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma BV," the filing said. Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of USD 28 million for twelve months ending September 2019 according to IQVIA.
Alembic has a cumulative total of 111 ANDA approval -- 99 final approvals and 12 tentative approvals -- from USFDA. The shares of Alembic Pharmaceuticals Ltd were trading at Rs 573, up 1.96 percent on BSE in morning trade.
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)
- READ MORE ON:
- Alembic Pharmaceuticals
- Tizanidine
- ANDA
- Food & Drug Administration
- IQVIA
- BSE
ALSO READ
New Slander Trial Against Amanda Knox in Italy Despite Previous Exoneration
Maharashtra Congress Chief Nana Patole unharmed in car accident as truck collides with vehicle in Bhandara
EU gives coffee exporter Uganda $43 mln to help it comply with forest policy
Maharashtra Congress chief Nana Patole escapes unhurt after truck rams into his car in Bhandara
DCM Shriram gets Rs 100 cr sustainable finance from Standard Chartered Bank